ORTHOLINK. 2 - Hole Wedge Osteotomy Plate SURGICAL TECHNIQUE
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1 MAXLOCK EXTREME ORTHOLINK 2 - Hole Wedge Osteotomy Plate SURGICAL TECHNIQUE
2 Contents Key Design Features 3 Surgical Technique 4 Implants and Instruments 7 Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting Wright Medical. Please contact your local Wright representative for product availability. 2
3 Key Design Features The ORTHOLINK 2-Hole Wedge Osteotomy Plate is intended for wedge osteotomies of the mid and hindfoot, such as Cotton and Evans osteotomies. The plate s combination of locking hole geometry and spacing fins provides secure correction fixation both during surgery and during recovery. The osteotomy spacing fins are designed to allow for more bone to grow in the osteotomy site during healing. The ORTHOLINK 2-Hole Wedge Osteotomy plate is compatible with the 3.5 mm fixed angle locking and the 2.7 mm, 3.5 mm and 4.0 mm non-locking screws of the MAXLOCK EXTREME system. Optional 3.5 mm variable angle locking screws are also available. 3
4 Surgical Technique Surgical technique Step 1 The surgical site is prepared and the osteotomy is cut and temporarily stabilized by the surgeon s preferred technique. A wedge template is available for determining the appropriate osteotomy cut location when the position of the plate profile is set relative to the joint space. A locking guide can be connected to the template for use as a handle. Position the plate profile as desired with respect to the joint location and mark the osteotomy cut line on the bone with a marking pen or scalpel along the flat face of the template. Depending on the procedure and surgeon preference, one should consider maintaining the far cortex of the osteotomy. Note: Always remove the template before cutting the osteotomy to avoid damage to the template. Step 2 The initial mobility of the osteotomy can be assessed with an osteotome. The osteotomy cut can be extended in an incremental manner until the site is mobile enough for distraction. Distract, using manual manipulation, osteotomes, or other distraction instruments, until the desired correction is attained. The medial wedge distractor is available to spread the osteotomy site and maintain that position until the desired implant is in position. Note: Verifying correction with fluoroscopy is recommended. CAUTION: In pediatric patients, avoid crossing the growth plate with any implants. Step 3 4 Measure the osteotomy opening with the 2-hole wedge plate spacer to determine the appropriate wedge size. Insert the ramped edge of the spacer into the osteotomy until the desired correction is achieved, then move the spacer slide until it contacts both edges of the osteotomy. The corresponding wedge size is depicted on the back end of the slide. Select the appropriate ORTHOLINK 2-Hole Wedge Osteotomy Plate and place the plate into the osteotomy site to verify fit. Care must be taken not to scratch or notch the implants throughout the procedure.
5 Step 4 If necessary, use the plate bending pliers to contour the plate to the bone surface. Each bend should be done in one direction only. Reverse or over bending may cause reduced fatigue life. Avoid excessive bending through or near the locking holes. If the plate is contoured through the locking holes, a non-locking screw is recommended to avoid crossthreading of the locking screw. If the plate is bent near a locking hole, thread in the locking drill guide to ensure the integrity of the threads in the plate. Step 5 The plate can be temporarily held in position with olive wires so the construct can be reviewed under fluoroscopy. The osteotomy opening can be filled with bone graft material before or after plate fixation according to surgeon preference. Three color-coded drill bits that correspond with the screws are provided in the system: 1.9 mm (gold), 2.4 mm (magenta) and 2.7 mm (aqua) diameters. The 1.9 mm bit is to be used in conjunction with 2.7 mm screws, the 2.4 mm bit is to be used in conjunction with 3.5 mm screws, and the 2.7 mm bit is to be used in conjunction with 4.0 mm screws. Screw diameter is chosen based on indication and surgeon preference; a combination of screws may be used in the same plate. When drilling for non-locking screws, the centered drill guide tips should be used. The drill guide tips are color coded to match the appropriate drill bit and screw diameter. To drill for a fixed angle locking screw, use the fixed drill guide. The fixed drill guide threads into the locking hole to provide the proper angle for drilling. Take care not to move the plate after drilling for a fixed angle locking screw hole in order to maintain the proper pilot hole alignment and prevent locking screw cross-threading. 5
6 Step 6 Drill to the desired depth. Use only the provided depth gauge to determine screw length. For all screws used throughout the procedure, verify screw length in the appropriate gauge on the screw caddy. Note: The depth gauge reading corresponds to the working length of the screw (from distal tip to underneath the screw head) Step 7 Remove the drill guide and place the appropriate screw in the hole. Use the HEXSTAR driver to insert the screw into the hole and drive the screw. Note: It is recommended that the surgeon use fluoroscopy to verify screw length and placement. Note: Do not over torque the screws. Driver or implant damage may result. Step 8 Correct placement of the fixation device is verified. The soft tissues are replaced as required by the operative procedure and surgeon preferred technique. 6
7 Ordering Information Implants and Instruments PLATES Description Part # 2 mm Wedge Plate COW mm Wedge Plate COW mm Wedge Plate COW mm Wedge Plate COW mm Wedge Plate COW mm Wedge Plate COW mm Wedge Plate COW mm Wedge Plate COW mm Wedge Plate MOW mm Wedge Plate MOW mm Wedge Plate MOW mm Wedge Plate MOW mm Wedge Plate MOW Wedge Template COW-061 Template A MOW-061-A Template B MOW-061-B Olive Wire MFT-040 Spacer COW-059 Medial Spacer MOW-059 Wedge Distractor MOW-068 7
8 SCREWS 2.7 mm Non-Locking Screws Description Part # ø2.7 8 mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT mm Non-Locking Screws Description Part # ø3.5 8 mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT
9 SCREWS 3.5 mm Fixed Angle Locking Screws Description Part # ø3.5 8 mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT mm Non-Locking Screws Description Part # ø4.0 8 mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT
10 INSTRUMENTS Description Part # Plate Bending Pliers MXS-051 Bending Irons MXL mm Depth Gauge CAT ø2.4 mm Fixed Guide w/ Depth Gauge MFT FDG ø2.4 mm Keyway Drill Guide MFT KG Ratcheting Handle DRV-057 Non-Ratcheting Handle MFT-057 HEXSTAR Driver Tapered MXS-056-T ø1.9 mm Drill Bit MFT ø2.4 mm Drill Bit MFT ø2.7 mm Drill Bit MFT ø3.5 mm Lag Drill Bit MFT ø4.0 mm Lag Drill Bit MFT Drill Guide Handle MFT-171 ø1.9 mm Centered Guide Tip MFT C ø1.9 mm Offset Drill Guide Tip MFT O ø2.4 mm Centered Guide Tip MFT C ø2.4 mm Offset Drill Guide Tip MFT O ø2.7 mm Centered Guide Tip MFT C ø2.7 mm Offset Drill Guide Tip MFT O ø3.5 mm Centered Guide Tip MFT C ø4.0 mm Centered Guide Tip MFT C 10
11 Notes 11
12 1023 Cherry Road Memphis, TN Nesbitt Avenue South Bloomington, MN Trademarks and Registered marks of Wright Medical Group N.V. or its affiliates Wright Medical Group N.V. or its affiliates. All Rights Reserved. MXE Rev B ECN Apr-2016
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