Technical Guideline. MONDE foot. Technical and clinical information. Foot Surgery. M2 Modular Foot-Osteosynthesis System.

Transcription

1 Technical Guideline Technical and clinical information MONDE foot Module 1 Module 2 Module 3 Cannulated System M2 Modular Foot-Osteosynthesis System Module 1 Module 2 Module 3 Module 4 Foot Surgery

2 MONDE foot M2 Table of contents Features, Areas of Application Page 3-4 Overview, Cannulated System Page 5 - Screws Page Plates Page Instruments Page Clinical Cases Page Cannulated System - Screws Page Instruments Page Step by Step instruction: Insertion of cann. screw Page Clinical Cases Page Containers Page

3 The preconfigured foot system M2 Osteosynthesis System Module 1 Module 2 Module 3 Features Extensive selection of plates and screws Multi-directional screw fixation for plates (locking, non-locking) Modular system with user-specific configuration option Individual container assembly Integration of all standard sterile containers possible Cannulated System Module 1 Module 2 Module 3 Module 4 The M2 system consists of two subsystems: 3 modules for the forefoot, midfoot and hindfoot cover the whole spectrum of orthopedic foot surgery including trauma surgery. Modul 1: Indications in the area of the forefoot e.g. plating for forefoot treatment having arthrodesis (hammertoe correction), hallux correction or shortening osteotomies. Module 2: Implants for the treatment of all pathologies in the midfoot area in the context of trauma or degenerative causes. These are applicable to hallux corrections, Lapidus arthrodesis, Lisfranc injuries or midfoot reconstructions (such as talonavicular arthrodesis). Modul 3: Implants can be applied for all corrections of the hindfoot (fracture treatment of the calcaneus as well as application of complex revision cases). Cannulated System As a part of the cannulated screw system, there is a division into 4 modules which also allow all treatments between the forefoot and the hindfoot. 3

4 Areas of Application Hammertoe corrections Lisfranc fusion Midfoot Reconstruction Medial Column Fusion CC fusion Calcaneus fracture Calcaneus-Slide-osteotomy Talonaviculare fusion MTPJ fusion Lapidus fusion Benefi ts of titanium for implants In general, pure titanium (DIN EN ISO /ASTM F67) is used for the manufacturing of bone plates while the titanium alloy (DIN EN ISO /ASTM F136) is used for the manufacturing of bone screws. Worldwide, these materials are used for short and long-term implants in the osteosynthesis for decades. For the following reasons: Completely biocompatible Corrosion-resistant Non-toxic in the biological environment Failure-free imaging with X-rays, computed tomography (CT) and magnetic resonance imaging (MRI) 4

5 Overview Sub-Systems Module 1 Module 2 Module 3 Plates Screws Locking (fully threaded) Non Locking (fully threaded) Cannulated System Module 1 Module 2 Module 3 Modul 4 Screws Cannulated (fully threaded) Cannulated (partially threaded) 5

6 Implants Screws Features & Advantages Screw head-design self-retaining Safe self-retaining mechanism of screw and screwdriver blade Easy and simple removal of screw Connection type: MCD (Mondeal Contour Drive) Screw thread self-tapping Optimal self-tapping ability thanks to sharp and precise thread Stable fixation in the bone Forward as well as backward tapping flutes Atraumatic screw tip avoids impairments and irritations of the soft tissue Gently for patient Screw tip atraumatic Overview screws Ø Length Module Screw (Ø in mm) Locking fully threaded (Lengths in mm) Non locking fully threaded (Lengths in mm) /8/10/12/14/16/18/20/22 6/8/10/12/14/16/18/20/22 6/8/10/12/14/16/18/20/22 6/8/10/12/14/16/18/20/ /10/12/14/16/18/20/22/24/26/28/30 8/10/12/14/16/18/20/22/24/26/28/30 8/10/12/14/16/18/20/22/24/26/28/30 32/34/36/38/40 8/10/12/14/16/18/20/22/24/26/28/30/32/34 36/38/40/42/44/46/48/50/52/54/56/68/ /12/14/16/18/20/22/24/26/28/30 32/3436/38/40/42/44/46/48/50/55/60 10/12/14/16/18/20/22/24/26/28/30 32/3436/38/40/42/44/46/48/50/55/60 10/12/14/16/18/20/22/24/26/28/30 32/3436/38/40/42/44/46/48/50/55/60 10/12/14/16/18/20/22/24/26/28/30 32/3436/38/40/42/44/46/48/50/55/60 6

7 Implants Screws Features & Advantages Notes for fi xed-angularity Having a fixed-angle (locking) screw, mind that during pre-drilling there is a drill sleeve screwed into the thread of the plate, which specifies the direction of drilling and also the desired position of the screw in the bone. This position is secured by screwing the external thread of the screw head with the internal thread of the hole of the plate the basis of an locking system. The screw head lines up precisely with the plate and gives a form that cannot be found in conventional nonlocking screws- and plating-systems with regard to its stability. Thanks to the reduced contact area between plate and bone, the power transmission also is a positive result of this method because the plate is not pressed on the bone but only in contact with it since the fixation of the screw takes place in the internal thread of the plate. This method in turn is less suitable when the screw shall be used as compression screw to bring up a bone fragment to the plate. In this case, our non-locking system can be used. Screw head-design locking locking non locking 2 different screw head types: - locking (fixed angle), with external thread on the screw head - non locking, without threaded screw head Polyaxial blocking technology Thread plate hole Polyaxial (+/- 15 ) and locking (fixed angle) blocking High stability due to guying of the screw head in the plate area The blocking technology promotes an angularly stable junction between the screw with external thread and the internal thread of the plate hole. Inner-thread plate hole fixed angle blocking +/- 15 Outer-thread screw head 7

8 Implants Plates General features Module 3 Ø Module 2 For the plates, screws with various screw diameters can be used (both locking and non locking): Module 1 Module (Screws Ø in mm) Module (Screws Ø in mm) Module (Screws Ø in mm) K-wire holes for the temporary positioning of all the plates of Modules 2 and 3 Module 2 Module 3 8

9 Implants Plates Module 1 Thickness: 1.0 mm Compression path: 1.0 mm HT-Plates, straight (with compression hole) Plates, straight (with/without compression hole) T-Plates (with/without compression hole) Hammertoe corrections Phalangs Metatarsale Phalangs Metatarsale By inserting and tightening a screw in an oval compression hole, an active compression of various bone segments within the longitudinal axis of the compression hole is made possible. Phalangs with T-Plate Metatarsale with straight Plate Hammertoe correction with HT-Plate (HT = Hammer Toe) 9

10 Implants Plates Module 2 Compression path: 1.5 mm L-Plates (left / right) Thickness: 2.0 mm Lapidus-Fusion MTPJ-Plates (without compression holes) Thickness: 1.5 mm MTPJ-Fusion MTPJ-Plates (with compression holes) Thickness: 2.0 mm MTPJ-Fusion By screwing and fixing / tightening a non locking screw in an oval compression hole, an active compression of various bone segments within the longitudinal axis of the compression hole is made possible. MTPJ-Fusion with MTPJ-Plate (MTPJ = Metatarsophalangeal Joints) The MTPJ (in this version with compression holes) plate can be bent angular in the transversal plane between 0 and 8 degrees. Due to the hole-/plate-configuration, an additional screw can be insert any time beneath the plate without interfering with any plate screws. 10

11 Implants Plates Module 2 Compression path: 1.5 mm MD-Plates, left/right (with compression holes) Thickness: 1.5 mm Ludloffs - or Open based wedge - Osteotomies Mid Diaphyseal Fusion Plates, straight (with/without compression holes) Thickness: 1.5 mm Lisfranc Fusion T-Plate (with compression hole) Thickness: 2.0 mm Lapidus Fusion TN Fusion (TN = Talon Naviculare) Ludloffs - or Open based wedge - Osteotomies Mid Diaphyseal Fusion with MD-Plate (MD = Mid Diaphyseal) 11

12 Implants Plates Modul 2 Thickness: 1.5 mm Compression path: 1.5 mm 0mm 1mm 2mm 3mm Lapidus H-Plates without step step 1 mm step 2 mm step 3 mm Lapidus-Fusion with Lapidus H-Plate 12

13 Implants Plates Modul 2 Thickness: 1.5 mm MOW-Plates wedge 3 mm wedge 4 mm wedge 5 mm wedge 6 mm wedge 7 mm wedge 8 mm Open-Wedge-Osteotomy with MOW-Plate (MOW = Midfoot Open Wedge) 13

14 Implants Plates Modul 2 Thickness: 1.5 / 3.0 mm Compression path: 2.0 mm MRP-Plates left / right Reinforcement at fusion area for optimal power transmission Integration of a gliding hole with angled compression options (biomechanical benefit) Pre-contoured plate design for correct application on the metatarsal Midfoot reconstructions of medial column Surgical revisions after midfoot reconstructions Medial Colum Fusion with MRP-Plate (MRP = Midfoot Reconstruction Plate) 14

15 Implants Plates Modul 2 Thickness: 1.5 mm DPS-Plates step 4 mm step 6 mm step 10 mm The DPS plate is used for correction of the calcaneus malposition. There is a Calcaneus-Osteotomy performed to bring the proximal calcaneus back into a more proper medial alignment. Calcaneus-Slide-Osteotomy with DPS-Plate (DPS = Displacement step) 15

16 Implants Plates Modul 2 Thickness: 2.0 mm X-Plate, S (Small) X-Plate, M (Medium) X-Plate, L (Large) Lisfranc-Fusion CC-Fusion (CC = Calcaneo Cuboid) with X-Plate 16

17 Implants Plates Modul 3 Thickness: 1.5 / 3.0 mm Compression path: 2.0 mm MRP-Plates left / right Reinforcement at fusion area for optimal power transmission Integration of a gliding hole with angled compression options (biomechanical benefit) Pre-contoured plate design for correct application on the metatarsal MRP plates as in Module 2, but more stable screws (with a larger diameter) can be used from Module 3: (Screw Ø in mm) Midfoot reconstructions of medial column Surgical revisions after midfoot reconstructions Medial Colum Fusion with MRP-Plate (MRP = Midfoot Reconstruction Plate) 17

18 Implants Plates Modul 3 Thickness: 1.5 mm Calcaneus-Plates, left/right Small Medium Large Calcaneus fractures with Calcaneus-Plate 18

19 Instruments for screws Screw-receiving and fixation Module Screwdriver handles Blade (Connection AO) Color code Type self-retaining 1 MCD not self-retaining self-retaining 2 MCD not self-retaining self-retaining 3 MCD not self-retaining Screw Removal Set, consisting of: Screwdriver handle Blades, not self-retaining Container 19

20 Instruments for screws Screw-receiving and fixation Assembly of blade and screwdriver handle 1 2 The arrow head of the screwdriver and the flat blade shank of the AO connection must face each other. Pull back the chuck of the screwdriver and insert the blade. Once the blade is locked, leave the chuck off again. 3 4 The screwdriver has a ratchet mechanism. If this is actuated forward, clockwise rotation is set (e.g. for inserting a screw). When the ratchet mechanism is actuated rearward, the left turn is set (e.g. for removing a screw). 20

21 Instruments for screws Screw-receiving and fixation Screw-receiving out of the tray with self-retaining blade Insert screwdriver blade into the screw head and press firmly. Remove the screw vertically. Notes from General IFU: Connection screwdriver and screw head It is essential to ensure that the screwdriver/screw head connection is aligned exactly in the vertical direction; otherwise, there is an increased risk of mechanical damage to the implant or the screwdriver. When engaging the bone screw, axial pressure of the screwdriver into the screw head must be adequately applied to ensure that the blade is fully inserted into the screw head. This results in axial alignment and full contact between screwdriver and screw. 21

22 Instruments for screws Drilling Drills: Identifi cation / Color Codes Thin Ring = Pilot Drill 1. Ring = Screw Color 2. Ring = Modular Color Wide Ring = Gliding Hole Drill Module 1 Module 2 Module 3 Drill Color Code Screws K-wires (Holes for temporary plate positioning) Diameter Ø Length Ø 1.5 mm Length 70 mm K-wire with olive is used for the fixation in the screw holes of the plate. Different diameters of the olive: for Module 1 Ø Olive 4 mm for Module 2 Ø Olive 5 mm for Module 3 Ø Olive 6 mm Ø 1.0 mm Length 150 mm K-wire with or without thread is used for the fixation in the small holes of the plate for Module 2 and Module 3 22

23 Instruments for screws Drilling Length Drills Diameter Ø Working Length for Screws Color Code Type Diameter x Length Working Length (WL) Connection 2.0 Pilot Drill 1.4 x 86 mm 26 mm Module Gliding Hole Drill 2.1 x 80 mm 20 mm Pilot Drill 1.7 x 86 mm 26 mm AO Gliding Hole Drill 2.4 x 80 mm 20 mm Pilot Drill 1.8 x 95 mm 35 mm 2.7 Module 3 Module Gliding Hole Drill 2.8 x 80 mm 20 mm Pilot Drill 2.1 x 125 mm 65 mm Gliding Hole Drill 3.1 x 80 mm 30 mm Pilot Drill 2.3 x 125 mm 65 mm Gliding Hole Drill 3.6 x 95 mm 45 mm Pilot Drill 2.8 x 125 mm 65 mm AO AO Gliding Hole Drill 4.1 x 95 mm 45 mm 23

24 Instruments for screws Drilling Notes from General IFU: Drills Small Drills are recommended for single use only. Damage is difficult to detect due to the small dimensions. Drills are provided with depth stops to prevent accidental penetration beyond the targeted bone. A drilling speed of rpm must be maintained to avoid overheating and bone necrosis. When using high speed power sources, the user must verify with the manufacturer a setting that corresponds to a maximum speed of 800 rpm. When using twist drills, it is essential to provide adequate cooling by means of copious normal saline irrigation (NaCl) to minimize thermal damage to the bone tissue. The combination of cooling and low speed (<800 rpm) significantly contribute to the reduction of screw loosening due to bone de-mineralization. Twist drills are developed and indicated for work at low speeds (<800 rpm). Higher rates of rotations may result in failure of the drill and potential injury to the user, patient or third parties. Axial guidance of the drill considerably reduces the risk of breakage and wear. Always use the shortest drill possible given the clinical indication. Longer drills are naturally susceptible to more eccentric rotation, especially when operated in air, free of resistance. The user must verify the compatibility of the drill with the attachment hand piece. In addition, regular maintenance and inspection of the hand piece are essential to prevent damage to the drill. 24

25 Instruments for screws Drilling Drilling guides Module 1 for pilot drills Ø 1.4 mm Ø 1.7 mm Module 2 for pilot drills Ø 1.8 mm Ø 2.1 mm Module 3 not relevant for for pilot drills Ø 2.3 mm Ø 2.8 mm Notes from General IFU: Drill guides Centric and eccentric drill guides (in conjunction with compression plates) ensure a low-strain seat of the bone screw in the bone plate and thus, make maximum axial compression possible (for compression techniques). 25

26 Instruments for screws Measuring Depth measuring gauge (Measuring range 0-50 mm) for Module 1 and Module 2 Depth measuring gauge (Measuring range 0-80 mm) for Module 3 Characteristics: Double-sided scale: suitable for right- and left-handers Probe with barb for exact measurement Can be completely dismantled for cleaning Notes from General IFU: Depth measuring gauges A depth gauge can be used to measure the depth of the hole drilled to determine the length of the bone screw to be inserted. If not otherwise expressly specified, the screw length is measured by the plate hole (i.e. applied plate). The value displayed on the scale of the depth gauge corresponds to the entire length of the bone screw. The length specified on the packaging label is the entire length of the bone screw. The screw measuring scale of the implant tray is laid out on the entire length. If the depth gauge has an angled probe on the end of the sensor, the surface facing the body of the instrument is the measuring point and not the surface facing away from the body. Factors such as profile height, screw seat in the hole of the bone plate, etc. have been taken into account in the depth gauges according to the product system. 26

27 Instruments for screws Measuring Screws and K-Wire Measuring Plate Screws diameter K-wire diameter (only relevant for Cannulated System) For exact measurement, the screw has to be positioned with the screw head laterally aligned in the fitting slot. The scale on the right side measures the length of the screw if the screw is fixed on a self-retaining blade. Notes from General IFU: Measuring plates Measuring plates and screw measuring scales in trays are only intended for rough determination of screws in length and diameter. For diameter drilling jigs on the measuring plates, the screw must be carefully positioned and pulled out again to avoid jamming or stripping of the screw. When used improperly, particles of material could be transferred from the gauge to the screw. 27

28 Instruments for plates Bending and outlining Bending lever for Module 1 During vertical bending with the bending levers, the plate should be hold on two consecutive plate holes so that the shape of the intermediate plate hole does not get damaged. Bending pliers with 2 pins for 2 Module It should be avoided to bend the plate by alternating movements. The plate should be bend to the maximum extent of both jaw parts of the bending pliers contact each other. 28

29 Instruments for plates Bending and outlining During bending, the plate should be hold on two consecutive plate holes so that the shape of the intermediate plate hole does not get damaged. It should be avoided to bend the plate by alternating movements. The plate should be bend to the maximum extent of both jaw parts of the bending pliers contact each other. Bending pliers with pin for Module 2 and Module 3 (optional applicable for Module 1) Notes from General IFU: Bending instruments Bone plates can be easily, quickly and precisely adjusted to any possible surface using bending instruments. The cold process during the bending procedure increases the hardness of the titanium and decreases its flexibility. Therefore, it is essential that the required form of the implant be achieved with as few bending maneuvers as possible. Excessive bending can cause the plate to break postoperatively. The convergence of extreme angles and small bending radii must be avoided due to the risk of damage to the implant (cracks, deformed screw holes, etc.) detectable postoperatively on a microscopic level. In these cases, the implant must be replaced by a new implant bent with greater care. Deformed screw holes mean not only an increased risk of breakage of the implant in this area, but also mean complications in the precision placement of the screw head. 29

30 Instruments for plates Cutting The plate cutter for Module 1 and Module 2 cuts the plates and shapes the round plate geometry at the same time. This also reduces tissue irritations by application. Hint for crop mark Cutting areas for Moduel 1 / Module 2 plates Place the plate with the hole on the fitting pin of the plate cutter. The hint on the top shows on which side the cut takes place. The cutting edge should be always in the bar area between the holes using all the plate cutters available. 30

31 Instruments for plates Cutting Plate cutter for Module 3 Shortened plate segments can be deburred in this area. Notes from General IFU: Plate Cutting Instruments A plate cutting instrument may be used to divide a bone plate in the area of the connecting bridge between two screw holes. As a precaution when cutting a plate, the plate end to be cut should never be directed toward the patient or a third party to prevent the risk of injury from the plate segment spinning off. It is advisable to cover the plate segment to be cut with a towel or other material to prevent the segment from spinning off in the first place. The shortened bone plate segment should be de-burred after cutting (see matching de-burring instruments in the leaflet) to prevent injury to or irritation of the soft tissue. 31

32 Clinical Case 1 Patient with strong splayfoot and fallen arches in addition to beginning MTP destruction. Symptoms of pain and discomfort in the area of the TMT I joint in the sense of an arthrodesis. Correction by Lapidus arthordesis for the alignment of the intermetatarsal I-/ II-angle. Temporary K-wire fixation. 32

33 Clinical Case 1 Fusion by a MONDEAL T-plate (Module 2) including a seperate cannulated lag screw. 33

34 Clinical Case 2 MRP - Midfoot Reconstruction Plate (Developed in cooperation with Dr. Andreas Schirm) Surgical instructions for implantation of the MRP Covering of the extremity for the operation, application of a tourniquet at the thigh or lower leg for bloodless field (depending on the type of anesthesia consider use of a lower leg nerve catheter) Access to the planned fusion area at the midfoot (in case of surgical revision removal of the osteosynthesis material) Cancellous bone substitute material in fusion gap TMT-I Adjacent naviculocuneiforme joint for planned extension of fusion Fusion gap TMT-I Distraction of the joint and removal of residual cartilage resp. preparation of the fusion surface In case of bony defect additional application of bone substitute (iliac crest,block or chips) 34

35 Clinical Case 2 MRP - Midfoot Reconstruction Plate (Developed in cooperation with Dr. Andreas Schirm) Surgical instructions for implantation of the MRP Naviculo-cuneiforme joint Distal plate fixation Distraction of the proximal joint with removal of residual cartilage and preparation of the articular surface Application of the Midfoot Reconstruction Plate (MRP) and distal fixation at the MT-I-shaft (at least one locking screw) Oblique running compression hole with guide wire Application of the guide wire in the direction of the fusion-articular surfaces to bridge the fusion and possible compression 35

36 Clinical Case 2 MRP - Midfoot Reconstruction Plate (Developed in cooperation with Dr. Andreas Schirm) Surgical instructions for implantation of the MRP Documentation by X-ray control of correct guide wire application (fluoroscopy) 36

37 Clinical Case 2 MRP - Midfoot Reconstruction Plate (Developed in cooperation with Dr. Andreas Schirm) Surgical instructions for implantation of the MRP Oblique running compression screw Screw fixation in the medial cuneiforme bone (possibly also fixation of 2nd cuneiforme bone) Application of cannulated lag screw after measuring the length Fixation of the plate in the medial cuneiforme bone (if necessary also fixation of 2nd cuneiforme bone) with compression and/or locking screws Screw fixation in the naviculare bone Fixation in the navicular bone with compression and/or locking screws Image documentation 37

38 Implants Screws Cannulated System Features & Advantages Screw head-design not self-retaining Die Schraube wird mit einer Pinzette aus dem Behälter entnommen. Durch die niedrige Profilhöhe und den geringen Durchmesser lässt sich der Schraubenkopf optimal im Knochen versenken (Reduzierung der Weichteilirritationen). Connection type: MCD (Mondeal Contour Drive) Screw thread self-tapping Optimal self-tapping ability thanks to sharp and precise thread Stable fixation in the bone Forward and backward cutting flutes Fully threaded or partially threaded Screw-body cannulated Hollow screw (transfixion) for minimally invasive technique and guided insertion. For placing over a K-wire Cannulated screw fully threaded Cannulated screw partial threaded K-wire without thread K-wire with thread 38

39 Implants Screws Cannulated System Overview Screws Ø Length Module Screw (Ø in mm) Cannulated fully threaded (Lengths in mm) Cannulated partially threaded (Lengths in mm) /10/12/14/16/18/20/22/ /10/12/14/16/18/20/22/24/26 10/12/ /10/12/14/16/18/20/22/24/26/28/ /10/12/14/16/18/20/22/24/26/28/30/32/34 36/38/40/42/44/46/48/50/52/54/56/58/60 14/16/18/20/22/24/26/28/30/32/34/36 38/40/42/44/46/48/50/52/54/56/68/ /18/20/22/24/26/28/30/32/34/36/38 40/42/44/46/48/50/52/54/56/68/ /18/20/22/24/26/28/30/32/34/36/38 40/42/44/46/48/50/52/54/56/68/ /18/20/22/24/26/28/30/32/34/36/38 40/42/44/46/48/50/55/60/65/70 16/18/20/22/24/26/28/30/32/34/36/38 40/42/44/46/48/50/55/60/65/ /55/60/65/70/75/80/85/90 95/100/105/110/115/ part. threaded short part. threaded long 50/55/60/65/70/75/80/85/90 95/100/105/110/115/120 25/30/35/40/45/50/55/60 65/70/75/80/85/90/95 100/105/110/115/120 55/60/65/70/75/80/85/90/95/ /110/115/120/125/130/135/140 Benefi ts of titanium for implants In general, pure titanium (DIN EN ISO /ASTM F67) is used for the manufacturing of bone plates while the titanium alloy (DIN EN ISO /ASTM F136) is used for the manufacturing of bone screws. Worldwide, these materials are used for short and long-term implants in the osteosynthesis for decades. For the following reasons: Completely biocompatible Corrosion-resistant Non-toxic in the biological environment Failure-free imaging with X-rays, computed tomography (CT) and magnetic resonance imaging (MRI) 39

40 Instruments for screws Screw-receiving and fixation Cannulated System Module Screwdriver handles Blade (Connection AO) Color code Type 1 MCD not self-retaining 2 MCD not self-retaining 3 MCD not self-retaining 4 The screwdriver body is hollow inside (cannulated) so that long K-wires can be transfi xed. Length= 220 mm not self-retaining MCD Removing the (non self-retaining) screw from the tray with forceps Press the forceps on the sides so the lever arms at the head of the forceps open. Place it just under the screw head and grip the screw by dissipating / reducing pressure. Remove the screw vertically. 40

41 Instruments for screws Screw-receiving and fixation Cannulated System Assembly of blade (Countersink, Tap) screwdriver handle 1 2 The arrow head of the screwdriver and the flat blade shank of the AO connection must face each other. Pull back the chuck of the screwdriver and insert the blade. Once the blade is locked, leave the chuck off again. 3 4 The screwdriver has a ratchet mechanism. If this is actuated forward, clockwise rotation is set (e.g. for inserting a screw). When the ratchet mechanism is actuated rearward, the left turn is set (e.g. for removing a screw). Screw Removal Set, consisting of: Screwdriver handle Blades, not self-retaining Container 41

42 Instruments for screws Drilling Cannulated System Drills: Identifi cation / Color Codes Thin Ring = Pilot Drill 1. Ring = Screw Color 2. Ring = Modular Color Wide Ring = Gliding Hole Drill Cannulated System Module 1 Module 2 Module 3 Module 4 Drill Color Code Screws

43 Instruments for screws Drilling Cannulated System Length Drills Diameter Ø Working Length For Screws Color Code Type Diameter x Length Working Length (WL) Connection Module Gliding Hole Drill 2.2 x 77 mm 27 mm 2.3 Gliding Hole Drill 2.5 x 77 mm 27 mm Pilot Drill 1.8 x 90 mm 40 mm 2.7 Module 3 Module Gliding Hole Drill 2.8 x 77 mm 27 mm Pilot Drill 2.1 x 110 mm 60 mm Gliding Hole Drill 3.1 x 90 mm 40 mm Pilot Drill 2.3 x 124 mm 75 mm Gliding Hole Drill 3.6 x 98 mm 50 mm Pilot Drill 2.8 x 124 mm 75 mm Gliding Hole Drill 4.1 x 98 mm 50 mm AO Pilot Drill 3.3 x 124 mm 75 mm 4.5 Gliding Hole Drill 4.6 x 98 mm 50 mm Module Gliding Hole Drill 6.6 x 220 mm 40 mm 43

44 Instruments for screws Drilling Cannulated System Notes from General IFU: Drills Small Drills are recommended for single use only. Damage is difficult to detect due to the small dimensions. Drills are provided with depth stops to prevent accidental penetration beyond the targeted bone. A drilling speed of rpm must be maintained to avoid overheating and bone necrosis. When using high speed power sources, the user must verify with the manufacturer a setting that corresponds to a maximum speed of 800 rpm. When using twist drills, it is essential to provide adequate cooling by means of copious normal saline irrigation (NaCl) to minimize thermal damage to the bone tissue. The combination of cooling and low speed (<800 rpm) significantly contribute to the reduction of screw loosening due to bone de-mineralization. Twist drills are developed and indicated for work at low speeds (<800 rpm). Higher rates of rotations may result in failure of the drill and potential injury to the user, patient or third parties. Axial guidance of the drill considerably reduces the risk of breakage and wear. Always use the shortest drill possible given the clinical indication. Longer drills are naturally susceptible to more eccentric rotation, especially when operated in air, free of resistance. The user must verify the compatibility of the drill with the attachment hand piece. In addition, regular maintenance and inspection of the hand piece are essential to prevent damage to the drill. K-wires (zur Platzierung von kanülierten Schrauben) Module For Screws Diameter x Length Types x 150 mm - without thread x 150 mm x 150 mm x 150 mm x 200 mm - with thread - without thread - with thread - without thread - with thread - without thread - with thread - without thread with thread without thread 44

45 Instruments for screws Drilling Cannulated System Drill guides Module 1 for K-wires Ø 0.8 mm Module 2 for K-wires Ø 1.0 mm Module 3 for K-wires Ø 1.5 mm Ø 2.0 mm not relevant for Cannulated System Notes from General IFU: Drill guides Centric and eccentric drill guides (in conjunction with compression plates) ensure a low-strain seat of the bone screw in the bone plate and thus, make maximum axial compression possible (for compression techniques). 45

46 Instruments for screws Measuring Cannulated System Depth gauge for K-wire (Measuring range 0-60 mm) for Module 1 und Module 2 Depth gauge for K-wire (Measuring range 0-70 mm) for Module 3 Depth gauge for K-wire (Measuring range mm) for Module 4 When using the gages, following points must be observed: Determining the screw length must always happen before drilling and with the aid of the K-wire. If the screw head shall be flush-mounted, do not read the screw length before using the countersink. Slide the gage over the K-wire to the bone. The end of the K-wire shows the total length of the required screw on the scale (incl. screw head). Notes from General IFU: Depth measuring gauges A depth gauge can be used to measure the depth of the hole drilled to determine the length of the bone screw to be inserted. The value displayed on the scale of the depth gauge corresponds to the entire length of the bone screw. The length specified on the packaging label is the entire length of the bone screw. The screw measuring scale of the implant tray is laid out on the entire length. 46

47 Instruments for screws Measuring Cannulated System Screws and K-Wire Measuring Plate Screws diameter K-wire diameter (only relevant for Cannulated System) For exact measurement, the screw has to be positioned with the screw head laterally aligned in the fitting slot. The scale on the right side measures the length of the screw if the screw is fixed on a self-retaining blade. Notes from General IFU: Measuring plates Measuring plates and screw measuring scales in trays are only intended for rough determination of screws in length and diameter. For diameter drilling jigs on the measuring plates, the screw must be carefully positioned and pulled out again to avoid jamming or stripping of the screw. When used improperly, particles of material could be transferred from the gauge to the screw. 47

48 Step-by-Step Instruction: Insertion of a cannulated screw Cannulated System 1 2 Introduction of the guidewire Insert the K-wire with the support of the drilling guide at the entry point of the final screw position in an appropriate depth. In case of pediatric bone or hard cortical bone, you can pre-drill a pilot hole with the solid drill. Flush-mounted screw head (optional) Having low soft tissue coverage, it is possible to achieve a further deepening by countersinking the screw head. Slide the gage over the K-wire and prepare the bone. 3 4 Using washers (optional) For highly osteoporotic bone or bone with thinner cortical bone, the use of a washer for mounting under the screw head is recommended. The additional contact face on the bone is spread by the load on a larger area and the countersinking of the screw head in the osteoporotic bone is minimized. Measurement of the screw length Slide the gage over the K-wire to the bone. The gage shows the measure until the tip of the K-wire. This ensures that the screw tip is placed at the same position as the tip of the K-wire before. The end of the K-wire shows the total length of the required screw on the scale (incl. screw head). 48

49 Step-by-Step Instruction: Insertion of a cannulated screw Cannulated System 5 6 Removing the screw out of the tray Press the forceps on the sides so the lever arms at the head of the forceps open. Place it just under the screw head and grip the screw by dissipating / reducing pressure. Remove the screw vertically. Putting the screw over the K-wire Start with the insertion of the screw over the K-wire by sliding it to the bone. 7 Insertion of the screw The screwdriver handle with blade is also positioned over the K-wire. Set the ratchet mechanism of the screwdriver to position R (for right-handed rotation) to be able to insert the screw clockwise. After final inspection and verification of the correct screw position, the K-wire can be removed. 49

50 Clinical Case 1 Cannulated System A screw traverses the entire rear part of the foot - excellent compression of the posterior facet Placement of a second positional screw (70 mm length) 50

51 Clinical Case 2 Cannulated System Picture showing a cannulated 6.5 mm MONDEAL lag screw. The sharp cutting tip and the MCD-Drive allow the surgeon to place the self-tapping screw easily and without great exertion of force between the already implanted plate and screws 51

52 Container Can be specifically configured to customers need Clear and systematic color coding Modular, economic M2 Modular Container System Completely modular The basic cases may be freely combined with tool inserts and modules of different implant sizes (on up to 3 levels). Individual configuration The screws, plates and instruments can be combined in different trays. Details can be adapted and also extended to the requirements of the individual user from the compact basic set to the extensive full range. Flexible color coding and labeling concept The use of colored clips in the module containers allow a lucid and consistent color coding of the individual implants and system sizes. Thus, a clear identification of the plates, screws and modules is enabled. 52

53 Container Up to 3 levels can be stacked in the basic case. (Condition: All inlay carriers are flat versions) 3 rd level: Inlay carrier flat 2 nd level: Inlay carrier flat 2 nd +3 rd level: Inlay carrier high 1 st level: Inlay carrier flat 1. Ebene: Inlay carrier flat There exist two different heights for the inlay carriers. Screws > 28 mm length high Drills / instruments Plates Screws <= 28 mm length flat 53

54 Notes 54

55 Notes 55

56 High Quality Implants Made by MONDEAL We reserve the right to make catalog and design changes arising from further developments and modifications. Pictures, product descriptions and texts are the property of MONDEAL Medical Systems GmbH. Further use and reproduction by Third Parties requires written consent from MONDEAL Medical Systems GmbH. All rights reserved! Note: Responsibility for the selection of the patient, for adequate training as well as the decision as to the choice and use of the implants, a post-operative removal or retention of implants is the sole decision of the surgeon. All brands and logos referred to in this brochure, registered by Third Parties, are subject without restriction to the legal provisions currently in force and to the rights of ownership of the respective registered owner MONDEAL Medical Systems GmbH Am Gewerbering Mühlheim a. d. Donau/Germany Phone Fax mail@mondeal.de 97-T301-D M2 01/ 11-15