DLS Dynamic Locking Screw. Combined with LCP Locking Compression Plate.

Transcription

1 DLS Dynamic Locking Screw. Combined with LCP Locking Compression Plate. Instructions for Use Discontinued June 2016 DSEM/TRM/0517/0844(1)

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3 Table of Contents Introduction DLS Dynamic Locking Screw 2 Indications 5 Instructions for Use Dynamic Locking Screw Technique 6 Compatibility with the LCP Percutaneous 13 Instrument System 3.5 Implant Removal 14 Product Information Technical Information 15 Implants 16 Instruments for DLS 3.7 mm 18 Instruments for DLS 5.0 mm 20 Image intensifier control Warning This description alone does not provide sufficient background for direct use of the product. Instruction by a surgeon experienced in handling this product is highly recommended. Reprocessing, Care and Maintenance of Synthes Instruments For general guidelines, function control and dismantling of multi-part instruments, please refer to: Dynamic Locking Screw Instructions for Use Synthes 1

4 DLS Dynamic Locking Screw. Combined with LCP Locking Compression Plate. DLS Dynamic Locking Screw Angular stable screw Locking screws can be placed in each threaded hole of the appropriate LCP. Stardrive recess. For better torque transmission. Screws lock tightly in the plate to: eliminate tension on the bone eliminate compression between plate and bone protect periosteum from potential damage and retain circulation Pin-sleeve design of the DLS allows micro-motion within the angular stable system. DLS can be used with all Synthes titanium or stainless steel locking plates. Cobalt chromium molybdenum alloy (CoCrMo) enables DLS to be as strong as standard locking screws. CoCrMo encourages less ingrowth and facilitates screw removal similar to stainless steel screws. Laserwelded. For stable fixation between pin and sleeve. 2 Synthes Dynamic Locking Screw Instructions for Use

5 Principle of Dynamic Locking Screw (DLS) Standard locking head. Compatible with all Synthes locking plates. DLS allows surgeons to modulate the rigidity of the locked plate construct for better load distribution. Pin-sleeve design. Micro-motion within the screw. DLS construct can deliver nearly parallel fracture site motion. Standard thread in the shaft. For strong anchorage in bone. Boosting biological bone healing: Micro-motions on the plate-side of the locking construct improve circumferential callus formation. New screw tip. Rounded tip and five flute design. Dynamic Locking Screw Instructions for Use Synthes 3

6 LCP Locking Compression Plate Provides angular stable support of fragments regardless of bone quality Reduces risk of primary and secondary loss of reduction even under high dynamic loading Reduces impairment of periosteal blood supply due to limited plateperiosteum contact Maintains favorable hold in osteoporotic bone and multiple fragment fractures LCP combi-hole B A A. Stable plate-screw connection Locking screws reduce screw loosening Excessive torque is not applied to the cortical bone The conical screw head facilitates screw insertion B. Compatibility The proven dynamic compression hole allows for use of all standard screws DLS Self-tapping dynamic locking screw Requires precise measurement of length (diaphysis and metaphysis) Bicortical use in the shaft Not necessary to separately tap thread Standard screw Dynamic compression is created by the eccentric insertion of the standard screw (analogous to LC-DCP) Self-tapping locking screw Requires precise measurement of length (metaphysis) Monocortical or bicortical use Not necessary to separately tap thread 4 Synthes Dynamic Locking Screw Instructions for Use

7 Indications Synthes Dynamic Locking Screws (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for the fixation of metaphyseal and diaphyseal shaft fractures of long bones (humerus, femur and tibia). The DLS allows micro-motion within the angular stable system. Synthes offers a wide selection of LCP plates, which covers a correspondingly extensive variety of indications. For this reason, this technical guide does not cover specific indications or the selection of a plate type for specific clinical situations. For treatment of these subjects, please refer to AO Principles of Fracture Management, courses offered by the AO ( and the corresponding professional literature. For general purposes, the following techniques for handling the implants and instruments will be demonstrated with a straight 3.5 mm LCP and DLS 3.7 mm. Important: The DLS 3.7 mm has a 0.2 mm larger shaft thread diameter compared to the standard locking screw 3.5 mm. Therefore dedicated instruments for DLS 3.7 mm (drill bit and drill sleeve) have to be used. The other instruments stay the same. Standard locking screw 5.0 instrumentation can be used for the DLS 5.0 (see pages 19 and 20). Dynamic Locking Screw Instructions for Use Synthes 5

8 Dynamic Locking Screw Technique 1 Reduce and fix fracture Reduce the fracture under image intensification. As needed, provide fixation with a Kirschner wire or reduction forceps. 2 Bend plate Instruments Bending Iron for Plates 2.4 to 3.5 length 145 mm (for use with ) Bending Iron for Plates 2.4 to 3.5 length 145 mm (for use with ) Bending Pliers for Plates 2.4 to 4.0, length 230 mm Bending Pliers for Reconstruction Plates 2.7 and 3.5 Adapt the LCP plate to the anatomy using the appropriate bending instruments (as for standard plates), especially in the case of joint fractures. Notes Do not bend the plate back and forth. The LCP combi-holes are asymmetrical in the plate. In straight plates, the hole alignment changes in the middle of the plate. This asymmetry enables exertion of unidirectional dynamic compression. 6 Synthes Dynamic Locking Screw Instructions for Use

9 3 Position and fix plate Position and fix the plate on the bone. Important: Before setting the first dynamic locking screw, ensure that the plate is provisionally well fixed in place. Otherwise the plate may rotate during screw locking, causing damage to surrounding soft tissue. Dynamic Locking Screw Instructions for Use Synthes 7

10 Dynamic Locking Screw Technique 4 Prepare DLS drill sleeve Instrument DLS Drill Sleeve 3.7, for Drill Bits 3.1 mm Carefully screw the DLS drill sleeve into the desired LCP hole until it is gripped completely by the thread. The DLS drill sleeve ensures that the dynamic locking screw is correctly locked in the plate. Angular stability is reduced if a locking screw is inserted obliquely. Technique tip: To make it easier for the drill sleeve to locate the start of the thread, it may be useful to slightly rotate the drill sleeve counterclockwise. Note: In precontoured plates, the threaded holes might not be perpendicular to the plate surface due to the anatomy. Important: Only use the white color-coded DLS drill sleeve with the white color coded drill bit for DLS 3.7 mm. For the DLS 5.0 mm the standard drill sleeve and drill bit as for standard locking screws can be used. 8 Synthes Dynamic Locking Screw Instructions for Use

11 5 Predrill screw hole and determine screw length Instrument DLS Drill Bit 3.1 mm with Stop, length 165 mm, 2-flute, for Quick Coupling Carefully drill the screw hole using an appropriate drill bit. Remove the drill sleeve. Important: Only use the white color-coded DLS drill bit for DLS 3.7 mm to ensure the correctly sized drill hole. Example showing measured length of 24 mm. 6 Option: Determine screw length Instrument Depth Gauge Determine the screw length with the depth gauge. Example showing measured length of 24 mm. Dynamic Locking Screw Instructions for Use Synthes 9

12 Dynamic Locking Screw Technique 7 Insert Dynamic Locking Screw Instruments Torque Limiter, 1.5 Nm Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling Screwdriver Shaft T15, self-holding Handle for Torque Limiter Nos and Handle with Quick Coupling Before insertion of the first dynamic locking screw, anatomical reconstruction must have occurred. After insertion of the dynamic locking screws, additional reduction cannot be achieved without removing the dynamic locking screws. The dynamic locking screws can either be inserted with a power tool (without final locking) or manually and always with a torque limiter. Important Always insert the dynamic locking screw with the dedicated torque limiter. 3 or more dynamic locking screws must be inserted for each segment / fragment. Do not combine standard locking screws and/or standard screws with DLS in the same segment/fragment. This will nullify the dynamization and might overload the standard locking screw; however, one fragment can be fixed with a standard locking screw and another with DLS. Note: Do not press the plate onto the bone. This will nullify the dynamization. 10 Synthes Dynamic Locking Screw Instructions for Use

13 7a Insertion with power tool To insert the dynamic locking screw using a power tool, fit a torque limiter to the power tool. Then insert the screwdriver shaft into the torque limiter. Pick up the dynamic locking screw and insert it into the plate hole. To insert the screw, start the power tool slowly, increasing the speed and then reducing it again before the dynamic locking screw is fully tightened. Uncouple the power tool and mount the handle for torque limiter or the handle with quick coupling and manually tighten the screw. After one click, the optimum torque is reached. Notes To reduce the risk of stripping the screw head, do not lock dynamic locking screws at full speed. Screw head stripping can cause difficulty in removing the implant. For long screws and thick cortical bone, ensure sufficient cooling during insertion. Important: Always insert the dynamic locking screw with the dedicated torque limiter: DLS 3.7 mm TLA 1.5 Nm DLS 5.0 mm TLA 4.0 Nm Dynamic Locking Screw Instructions for Use Synthes 11

14 Dynamic Locking Screw Technique 7b Manual insertion To insert the dynamic locking screw manually, attach the torque limiter handle to the torque limiter and insert a screwdriver shaft. Screw in the dynamic locking screw, and lock it in the plate. Important Always insert and lock the dynamic locking screw with the dedicated torque limiter: DLS 3.7mm TLA 1.5 Nm DLS 5.0mm TLA 4.0 Nm The dynamic locking screw is only available with Stardrive recess and should only be used with the appropriate Stardrive screwdriver. Do not use the hexagonal screwdriver. Note: Under image intensification you can identify the pinsleeve design of the DLS. 12 Synthes Dynamic Locking Screw Instructions for Use

15 Compatibility with the LCP Percutaneous Instrument System 3.5 mm The LCP Percutaneous Instrument Set 3.5 mm consists of a comprehensive series of aiming arms and instrumentation to facilitate the percutaneous, submuscular insertion of various plates. The DLS 3.7 mm is compatible with the LCP Percutaneous Instrument System 3.5 mm. For the use of the DLS 3.7 with LCP Percutaneous Instrument System 3.5 the LCP Small Fragment Percutaneous Instrument Set 3.5 needs to be upgraded with the following instruments: Drill Bit 3.1 mm with Stop, calibrated, length 250/225 mm, for Quick Coupling Locking Drill Sleeve 3.1 mm, percutaneous For the complete instruction and technique details of the use of the LCP Percutaneous Instrument System 3.5 please refer to technique guide LCP Low Bend Medial Distal Tibia Plate Aiming Instruments 3.5 mm and LCP Per cutaneous Aiming System 3.5 for PHILOS Dynamic Locking Screw Instructions for Use Synthes 13

16 Implant Removal To remove the plate, first remove tissue and bone from all screw heads and drives. Insert a screwdriver in the screw recess and unlock all screws manually. Then completely remove all screws. If the screws cannot be removed with the screwdriver, consult the separate Synthes publication Screw Extraction Set: Instruments for removing Synthes screws (Art. No : pages (Situation B) and pages 44 47), which explains how broken screws can be removed. These are the specific instruments for the extraction of the dynamic locking screws: DLS 3.7 mm: Hollow Reamer, complete, anticlockwise cutting, for Screws 3.5 and 4.0 mm Spare Reamer Tube, for No Extraction Bolt, for Screws 3.5 and 4.0 mm Extraction Screw, conical, for Screws 1.5 and 2.0 mm Extraction Screw, conical, for Screws 2.7, 3.5 and 4.0 mm DLS 5.0 mm: Hollow Reamer, complete, anticlockwise cutting, for Screws 4.5 mm Spare Reamer Tube, for No Extraction Bolt, for Screws 4.5 and 5.0 mm Extraction Screw, conical, for Screws 2.7, 3.5 and 4.0 mm Extraction Screw for Screws 3.5 mm 14 Synthes Dynamic Locking Screw Instructions for Use

17 Technical Information Screw and pin lengths DLS 3.7 The two shortest screws (22 and 24 mm) have a shorter pin, and all longer screws (26 70 mm) have the same longer length pin. The result is a comparable elastic behavior across all screw lengths. DLS 5.0 The three shortest screws (32 36 mm) have a shorter pin, and all longer screws (38 90 mm) have the same longer length pin. The result is a comparable elastic behavior across all screw lengths. Short Pin * 22 and 24 mm Long Pin * * mm Short Pin mm Long Pin * * * mm * Maximum deflection 0.2 mm * Maximum deflection 0.35 mm Dynamic Locking Screw Instructions for Use Synthes 15

18 Implants DLS 3.7 Dynamic Locking Screw 3.7 mm, self-tapping CoCrMo Sterile Art no. Length (mm) S S S S S S S S S S S S S S S S S S S S S S S 70 Warning: Do not resterilize the Dynamic Locking Screw. 16 Synthes Dynamic Locking Screw Instructions for Use

19 DLS 5.0 Dynamic Locking Screw 5.0 mm, self-tapping CoCrMo Sterile Art no. Length (mm) S S S S S S S S S S S S S S S S S S 90 Warning: Do not resterilize the Dynamic Locking Screw. Dynamic Locking Screw Instructions for Use Synthes 17

20 Instruments for DLS 3.7 mm Dedicated instruments for DLS 3.7 mm DLS Drill Sleeve 3.7, for Drill Bits 3.1 mm DLS Drill Bit 3.1 mm with Stop, length 165 mm, 2-flute, for Quick Coupling Small fragment instruments Bending Iron for Plates 2.4 to 3.5, length 145 mm (for use with ) Bending Iron for Plates 2.4 to 3.5, length 145 mm (for use with ) Bending Pliers for Plates 2.4 to 4.0, length 230 mm Bending Pliers for Reconstruction Plates 2.7 and Depth Gauge for Screws 2.7 to 4.0 mm, measuring range up to 60 mm Torque Limiter, 1.5 Nm, for Compact Air Drive and for Power Drive Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling 18 Synthes Dynamic Locking Screw Instructions for Use

21 Screwdriver Shaft Stardrive 3.5, T15, self-holding, for AO/ASIF Quick Coupling Handle for Torque Limiter Nos and Handle with Quick Coupling Dynamic Locking Screw Instructions for Use Synthes 19

22 Instruments for DLS 5.0 mm Large fragment instruments LCP Drill Bit 4.3 mm with Stop, length 221 mm, 2-flute, for Quick Coupling LCP Drill Sleeve 5.0, for Drill Bits 4.3 mm Universal Drill Guide 4.5/3.2, for neutral and load position LCP Universal Drill Guide 4.5/ Screwdriver Shaft Stardrive 4.5/5.0, T25, self-holding, for AO/ASIF Quick Coupling Screwdriver Stardrive 4.5/5.0, T25, with Groove, length 240 mm 20 Synthes Dynamic Locking Screw Instructions for Use

23 Torque-limiting Screwdriver Stardrive, T25, self-holding, for Locking Screws 5.0 mm Holding Sleeve for Screws, for LCP 4.5/ Handle for Torque Limiter Nos and Torque Limiter, 4 Nm, for Compact Air Drive and Power Drive Dynamic Locking Screw Instructions for Use Synthes 21

24 All technique guides are available as PDF files at Ö öABNä version AB 10/ Synthes, Inc. or its affiliates Subject to modifications Synthes is a trademark of Synthes, Inc. or its affiliates