BioDrive Micro Screw System

Transcription

1 At Biomet, engineering excellence is our heritage and our passion. For over 25 years, through various divisions worldwide, we have applied the most advanced engineering and manufacturing technology to the development of highly durable systems for a wide variety of surgical applications. BioDrive Micro Screw System To learn more about this product, contact your local Biomet Sales Representative today. All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the sole use and benefit of the Biomet sales force and health care professionals. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet s website. Responsible Manufacturer Biomet, Inc. P.O. Box E. Bell Drive Warsaw, Indiana USA Rx only Biomet Orthopedics Form No. BMET REV

2 Surgical Technique BioDrive Micro Screw System Headless variable pitched compression screws specifically designed to stabilize small bone fragments around articular regions

3 Contents Introduction... Page 1 Indications and Contraindications... Page 2 Implant Specifications... Page 3 BioDrive Micro Screw Surgical Technique... Page 5 BioDrive Micro Nail Plate Surgical Technique... Page 8 Tray Layout... Page 12 Ordering Information... Page 14 Sterilization... Page 16 Further Information... Page 17 B

4 Introduction Available in diameters of 2.0 mm, 2.3 mm and 3.0 mm, the BioDrive Micro Screw System offers a wide range of cannulated and non-cannulated headless compression screws specifically designed to stabilize small bone fragments around articular regions. Longer pitched threads on the distal tip of the screw penetrate bone at a faster rate than the shorter trailing threads, allowing interfragmentary compression as the screw is advanced and countersunk. 2.0 mm BioDrive Micro Screw (Solid) 2.3 mm BioDrive Micro Screw (Cannulated) Self-drilling, self-tapping and self-countersinking Features: Headless design minimizes hardware prominence and soft tissue irritation Self-tapping screw threads minimize fracture site disruption during insertion 3.0 mm BioDrive Micro Screw (Cannulated) Small diameter sizes (2.0 mm, 2.3 mm and 3.0 mm ) and smooth central shaft minimizes bone loss during insertion Color-coded instrumentation facilitates intraoperative efficiencies Low profile Micro Nail Plate can provide interfragmentary compression and is well suited for areas of limited soft tissue coverage Micro Nail Plate with Fully Threaded 2.3 mm Cannulated Screw Material: Titanium Alloy 0.95 mm Plate Thickness 1

5 Indications and Contraindications Indications For Use For The BioDrive Micro Screw System The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures. Specifically: 1. Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, nonunions, or malunions 2. Ligament reconstruction 3. Osteochondritis dissecans 4. Arthrodesis of the foot, ankle, wrist, elbow and hand 5. Small bone osteotomies, including first metatarsal head osteotomy, metatarsal osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies Contraindications 1. Active infection. 2. Patient conditions including blood supply limitations, insufficient quantity or quality of bone. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 4. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device. These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis. 2

6 Implant Specifications 2.0 mm BioDrive Micro Screw (Solid) Lengths: 11 mm -14 mm (1.0 mm increments) Diameter: 3.4 mm Shaft Diameter: 1.2 mm Diameter: 2.0 mm Drill Bit Used: Catalog # FT150B (1.5 mm Solid Drill Bit, Gray Ringed) Proximal Thread Pitch: 0.6 mm Distal Thread Pitch: 0.8 mm Screw Driver Used: Catalog # TV200B (Solid 1.5 mm Hex Screw Driver, Green Ringed) 2.3 mm BioDrive Micro Screw (Cannulated) Lengths: 10 mm -28 mm (2.0 mm increments) Diameter: 3.4 mm Shaft Diameter: 1.6 mm Diameter: 2.3 mm Drill Bit Used: Catalog # FT230B (1.6 mm Cannulated Drill Bit, Blue and Gray Ringed) Proximal Thread Pitch: 0.8 mm Distal Thread Pitch: 1.0 mm Screw Driver Used: Catalog # TV230B (Cannulated 1.5 mm Hex Screw Driver, Blue and Gray Ringed) Countersink Used: Catalog # FR230B (Cannulated Countersink, Blue Ringed) 3

7 Implant Specifications (Continued) 3.0 mm BioDrive Micro Screw (Cannulated) Lengths: 10 mm -32 mm (2.0 mm increments) Diameter: 4.7 mm Shaft Diameter: 1.9 mm Diameter: 3.0 mm Drill Bit Used: Catalog # FT300B (1.9 mm Cannulated Drill Bit, Yellow Ringed) Proximal Thread Pitch: 1.05 mm Distal Thread Pitch: 1.25 mm Screw Driver Used: Catalog # TV300B (2.0 mm Cannulated Hex Screw Driver, Yellow Ringed) Countersink Used: Catalog # FR300B (Cannulated Countersink, Yellow Ringed) BioDrive Micro Nail Plate and Screw Screw Lengths: 11 mm -15 mm (1.0 mm increments) 6.0 mm 5.9 mm 3.2 mm Screw Diameter: 2.3 mm 0.95 mm Drill Bit Used for Screw: Catalog # FT230B (Cannulated 1.6 mm Drill Bit, Blue and Gray Ringed) 60 Length: 15 mm Drill Bit Used for Nail Portion: Catalog # FT150B (Solid 1.5 mm Drill Bit, Gray Ringed) Screw Driver Used: Catalog # TV230B (Cannulated 1.5 mm Hex Screw Driver, Blue and Gray Ringed) Micro Nail Plate with Inserter (Catalog # A2300B) 4

8 BioDrive Micro Screw Surgical Technique Demonstrated with the 2.3 mm BioDrive Micro Screw Step 1: Screw Site Preparation Figure 1 Shown: Long Arm Chevron Osteotomy of the First Metatarsal After sufficient surgical exposure is obtained, perform the appropriate osteotomy as indicated by procedure and surgeon preference (Figure 1). Once bone segments are properly aligned, K- wires can be inserted to temporary fixate the osteotomy and mark the prescribed path of the screw (Figure 2). Step 2: Guide Wire Placement For each screw used, a 0.8 mm x 120 mm K-Wire (Catalog # BR101DT) is inserted in the prescribed screw path. NOTE 1: Guide wires should hit, but not perforate the far cortex. When selecting the appropriate screw length, subtract approximately 2.0 mm to account for osteotomy gap compression as well as the desired amount of countersinking depth. NOTE 2: Bone Reduction Forceps (Catalog # DA000B) and Small Bone Holding Forceps (Catalog # 22894) are included in the set and can be used to temporarily hold the osteotomy in place while the screw site is prepared. Figure 2 Shown: (Two) 0.8 mm x 120 mm K-Wires inserted from distal-dorsal to proximal-planter Bone Reduction Forceps (Catalog # DA000B) Small Bone Holding Forceps (Catalog # 22894) 5

9 BioDrive Micro Screw Surgical Technique (Continued) Step 3: Screw Sizing and Pre-drilling When using the Wire Depth Gauge (Catalog # ), slide the tapered end over the guide wire down to the bone. The reading at the exposed end of the guide wire will indicate the appropriate screw length (Figure 3). NOTE 3: Although the BioDrive Micro Screws have cutting flutes, it is recommended that screw paths are pre-drilled to avoid the need for excessive insertion force. NOTE 4: When using the screw measuring scale on the caddy, the head of the screw must be held flush with the edge of the caddy to ensure accuracy. Figure 4 Using the color corresponding drill bit for the screw being utilized, drill over the guide wire (Figure 4). The Depth Gauge (Catalog # JA000B) can also be used to determine the screw lengths up to 28 mm (Figure 5). The set includes cannulated countersinks which can be utilized to ensure that screw heads seat fully recessed (Figure 6). (Available for 2.3 mm and 3.0 mm screws only) Figure 5 Depth Gauge (Catalog # JA000B) Figure 6 Figure 3 Wire Depth Gauge (Catalog # ) 6

10 Step 4: Screw Insertion Using the Ergonomic Handle (Catalog # MV000B) and the color corresponding screw driver, the screw is inserted over the guide wire (Figure 7). The varying thread pitches on the tip and head of the screw will allow for interfragmentary compression as the screw is passed and countersunk (Figure 8). Figure 7 Confirm accurate screw placement and bone alignment before addressing subsequent screws, which are prepared and inserted in the same fashion. Step 5: Wound Closure and Postoperative Care After all screws are fully implanted, check final screw position with image intensification. Guide wires are then removed and capsular closure is performed. Excessive plication of the capsule is not desirable. The incision is then closed and the extremity is bandaged. Figure 8 NOTE 5: In lower extremity procedures, it is advisable to place patients in a postoperative shoe or boot during the return to weight bearing. Patients are encouraged to perform range of motion exercises in the early postoperative period. 7

11 BioDrive Micro Nail Plate Surgical Technique BioDrive Micro Nail Plate Figure 1 Step 1: Osteotomy and Bone Realignment After sufficient surgical exposure is obtained, perform the appropriate osteotomy as indicated by procedure and surgeon preference. Once bone segments are properly aligned, pre-drilling can ensue. Step 2: Micro Nail Plate Insertion Preparation The Alignment Guide (Catalog # VA000B) is placed firmly against the cortex (Figure 1). Pass the 1.5 mm Solid Drill Bit (Gray Ringed, Catalog # FT150B) through the guide to create the hole for the nail portion of the nail plate (Figure 2). Detach the bit from the power drill and leave in place (Figure 3). Figure 2 Figure 3 Micro Nail Alignment Guide (Catalog # VA000B) 8

12 After drilling the nail portion of the nail plate, insert a 0.8 mm K-Wire through the wire hole of the Alignment Guide to the desired depth (Figure 4). The 1.5 mm Solid Drill Bit and the Alignment Guide are then removed, leaving behind the guide wire (Figure 5). The Wire Depth Gauge is then used to determine screw length. The reading at the exposed end of the guide wire will indicate the appropriate screw length. Figure 4 Wire Depth Gauge (Catalog # ) Drill over the guide wire to the appropriate depth using the 1.6 mm Cannulated Drill (Blue and Grey Ringed, Catalog # FT230B) (Figure 6). Figure 5 Static Screw Site Figure 6 NOTE 1: If compression is not desired, the static screw site on the Alignment Guide can be utilized. This static screw site is aligned with the center point of the nail plate s screw hole. 9

13 BioDrive Micro Nail Plate Surgical Technique (Continued) Step 4: Micro Nail Plate Insertion Attach the Nail Plate/Inserter (Catalog # A2300B) to the Ergonomic Handle and insert the nail portion of the nail plate into the proximal hole. The K-Wire should pass through the nail plate s screw hole as shown (Figure 7). Once the nail portion is fully implanted, the driver handle is detached and the nail plate inserter is removed. The screw is then inserted over the guide wire through the hole of the nail plate using the 1.5 mm Cannulated Hex Driver (Blue and Gray Ringed, Catalog # TV230B) (Figure 8). Figure 7 Following the guide wire s path through the nail plate s screw hole, a compressive force is exerted as the screw gains purchase. NOTE 2: Do not over-tighten the screw. Once screw head is flush with plate, stop turning. Do not reduce the nail plate to the bone using the screw (Figure 9). Figure 8 The distal fragment is compressed as screw gains purchase. Micro Nail Plate with Inserter (Catalog # A2300B) Figure 9 10

14 Step 5: Wound Closure and Postoperative Care Once the screw is fully seated, check final placement with image intensification prior to capsular and incision closure. Once the wound is closed, the extremity is then bandaged. It is advisable to place lower extremity patients in a postoperative shoe or boot during the return to weight bearing. Patients are encouraged to perform range of motion exercises in the early postoperative period. 11

15 Tray Layout Kit # Micro Nail Alignment Guide, Catalog # VA000B Small Bone Holding Forceps, Catalog # Large Bone Holding Forceps, Catalog # Bone Reduction Forceps, Catalog # DA000B Depth Gauge, Catalog # JA000B Wire Depth Gauge, Catalog # Ergonomic Handle, Catalog # MV000B Bone Lever, Catalog # SP000B Baby Hohmann Retractor, Catalog #

16 Implant Caddy Screw Drivers, Drill Bits and Countersinks mm Cannulated Hex Screw Driver (3.0 mm Screws), Catalog # TV300B 2. Cannulated Countersink (3.0 mm Screws), Catalog # FR300B mm Cannulated Drill Bit (3.0 mm Screws), Catalog # FT300B mm Solid Drill Bit (3.0 mm Screws), Catalog # FT301B mm Cannulated Hex Screw Driver (2.3 mm Screws/Nail Plate Screws), Catalog # TV230B 6. Cannulated Countersink (2.3 mm Screws), Catalog # FR230B mm Cannulated Drill Bit (2.3 mm Screws/Nail Plate Screws), Catalog # FT230B mm Solid Drill Bit (2.0 mm Screws), Catalog # FT150B mm Solid Hex Screw Driver (2.0 mm Screws), Catalog # TV200B Micro Nail Plate Screws 2.3 mm BioDrive Micro Screws 2.0 mm BioDrive Micro Screws 3.0 mm BioDrive Micro Screws Micro Nail Plates with Inserters, Catalog # A2300B K-Wires, 0.8 x 120 mm (double-tipped), Catalog # BR101DT 13

17 Ordering Information Implants Catalog # Description Qty. V2011B BioDrive Micro Bone Screw 2.0 mm L 11 mm 3 V2012B BioDrive Micro Bone Screw 2.0 mm L 12 mm 3 V2013B BioDrive Micro Bone Screw 2.0 mm L 13 mm 3 V2014B BioDrive Micro Bone Screw 2.0 mm L 14 mm 3 V2310B BioDrive Micro Bone Screw 2.3 mm L 10 mm 3 V2312B BioDrive Micro Bone Screw 2.3 mm L 12 mm 3 V2314B BioDrive Micro Bone Screw 2.3 mm L 14 mm 3 V2316B BioDrive Micro Bone Screw 2.3 mm L 16 mm 3 V2318B BioDrive Micro Bone Screw 2.3 mm L 18 mm 3 V2320B BioDrive Micro Bone Screw 2.3 mm L 20 mm 3 V2322B BioDrive Micro Bone Screw 2.3 mm L 22 mm 3 V2324B BioDrive Micro Bone Screw 2.3 mm L 24 mm 3 V2326B BioDrive Micro Bone Screw 2.3 mm L 26 mm 3 V2328B BioDrive Micro Bone Screw 2.3 mm L 28 mm 3 V3010B BioDrive Micro Bone Screw 3.0 mm L 10 mm 3 V3012B BioDrive Micro Bone Screw 3.0 mm L 12 mm 5 V3014B BioDrive Micro Bone Screw 3.0 mm L 14 mm 6 V3016B BioDrive Micro Bone Screw 3.0 mm L 16 mm 6 V3018B BioDrive Micro Bone Screw 3.0 mm L 18 mm 4 V3020B BioDrive Micro Bone Screw 3.0 mm L 20 mm 3 V3022B BioDrive Micro Bone Screw 3.0 mm L 22 mm 3 V3024B BioDrive Micro Bone Screw 3.0 mm L 24 mm 3 V3026B BioDrive Micro Bone Screw 3.0 mm L 26 mm 2 V3028B BioDrive Micro Bone Screw 3.0 mm L 28 mm 2 V3030B BioDrive Micro Bone Screw 3.0 mm L 30 mm 2 V3032B BioDrive Micro Bone Screw 3.0 mm L 32 mm 2 A2311B BioDrive Micro Bone Screw for Micro Nail Plate 2.3 mm L 11 mm 3 A2312B BioDrive Micro Bone Screw for Micro Nail Plate 2.3 mm L 12 mm 3 A2313B BioDrive Micro Bone Screw for Micro Nail Plate 2.3 mm L 13 mm 3 A2314B BioDrive Micro Bone Screw for Micro Nail Plate 2.3 mm L 14 mm 3 A2315B BioDrive Micro Bone Screw for Micro Nail Plate 2.3 mm L 15 mm 3 A2300B BioDrive Micro - Micro Nail Plate 2 14

18 Instruments and Disposables Catalog # Description Qty. FT301B BioDrive Micro 2.0 mm Solid Drill Bit (3.0 mm Screws) 2 FR300B BioDrive Micro Cannulated Countersink (3.0 mm Screws) 1 FT300B BioDrive Micro 1.9 mm Cannulated Drill Bit (3.0 mm Screws) 2 TV300B BioDrive Micro 2.0 mm Cannulated Hex Screw Driver (3.0 mm Screws) 2 FR230B BioDrive Micro Cannulated Countersink (2.3 mm Screws) 1 FT230B BioDrive Micro 1.6 mm Cannulated Drill Bit (2.3 mm Screws/Nail Plate Screws) 2 TV230B BioDrive Micro 1.5 mm Cannulated Hex Screw Driver (2.3 mm Screws/Nail Plate Screws) 2 TV200B BioDrive Micro 1.5 mm Solid Hex Screw Driver (2.0 mm Screws) 2 FT150B BioDrive Micro 1.5 mm Solid Drill Bit (2.0 mm Screws) 2 MV000B BioDrive Micro Ergonomic Handle - Quick A.O. Coupling 1 JA000B BioDrive Micro Depth Gauge 1 VA000B BioDrive Micro Alignment Guide for Micro Nail Plate 1 DA000B BioDrive Micro Bone Reduction Forceps 1 SP000B BioDrive Micro Bone Lever Small Bone Holding Forceps Large Bone Holding Forceps Baby Hohmann Retractor Wire Depth Gauge 1 BR101DT BioDrive Micro 0.8 mm x 120 mm K-Wire (double-tipped) (5 Per Pack) Replacement Tray Sterile Packed Disposables (Not included in set) Catalog # Description FT301BS BioDrive Micro 2.0 mm Solid Drill Bit (3.0 mm Screws) (Sterile) FT300BS BioDrive Micro 1.9 mm Cannulated Drill Bit (3.0 mm Screws) (Sterile) FT230BS BioDrive Micro 1.6 mm Cannulated Drill Bit (2.3 mm Screws) (Sterile) FT150BS BioDrive Micro 1.5 mm Solid Drill Bit (2.0 mm Screws) (Sterile) BR101DTS BioDrive Micro 0.8 mm x 120 mm K-Wire (Double-tipped) (5 Per Pack) (Sterile) 15

19 Sterilization The BioDrive Micro Screw System is provided in both sterile and non-sterile configurations. 1. The sterile system is provided sterile using a minimum dosage of 2.5 megarad (25 kgy) of gamma radiation. Where specified, do not use implants after expiration date. 2. The non-sterile system must be sterilized prior to use. All packaging materials must be removed prior to sterilization. All components should be sterilized in a loosened state such that components may move freely. 3. Re-sterilization of sterile products which have been opened is permissible as long as the components have not been previously implanted, not been exposed to biological contamination, nor appear to have compromised mechanical integrity. The following steam sterilization parameters are recommended: Cycle: Vacuum Steam Temperature: 270 F(132 C) Time: 8 minutes Recommended drying time: 20 minutes Individuals or hospitals not using the recommended method, temperature, and time are advised to validate any alternative methods or cycles using an approved method or standard. 16

20 Further Information This brochure describes a surgical technique used by Charles Zelen, D.P.M. and Selene Parekh, M.D. Biomet Trauma as the manufacturer of this device, does not recommend this product or any specific surgical technique for use on any individual patient. The surgeon who performs any implant procedure is responsible for determining the appropriate product(s) and utilizing the appropriate technique(s) for said implantation in each individual patient. The contents of this manual are intended to be only a guide and are not intended to set a standard of care. For further information, please contact the Customer Service Department at: Biomet Trauma 56 East Bell Drive P.O. Box 587 Warsaw, Indiana x CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. 17

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