MINI MAXLOCK EXTREME ISO Plate SURGICAL TECHNIQUE
Contents Table of Contents Key Design Features 2 Surgical Technique 3 Implants and Instruments 8 Key Design Features The MINI MAXLOCK EXTREME ISO (Intraosseous Sliding Osteotomy) Plate with POCKETLOCK Technology is intended to be used in cases where distal Chevron/Austin osteotomies are typically indicated. The ISO Plate combines the bending strength and rotational control of a plate with the compression generation of an inter-fragmentary screw. POCKETLOCK Technology provides the advantage of allowing the placement of an interfragmentary screw through a plate, using the plate to lock the construct in place to achieve optimal compression. This indication specific plate is designed to utilize the blade of the plate intraosseously to create a robust construct with excellent rotational and bending strength. This allows for more stable fixation of distal osteotomies. The custom bone prep instrumentation and the bottom-side pocket create a low profile construct with no exposed screw heads to cause soft-tissue irritation. 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
Note: This plate is intended for use in cases where a distal Chevron/Austin osteotomy is typically indicated. Prior to surgery, ensure that the anatomy is adequate for the plate size and amount of shift. Step 1 Perform a standard medial approach for the first metatarsal phalangeal joint. Step 2 Using a microsagittal saw, remove the medial eminence on the distal head of the first metatarsal and make a distal, transverse V-shaped osteotomy (Chevron/Austin) through the first metatarsal at least 12 mm from the articular surface. The cut should be made from medial to lateral. Note: To determine proper cut location: flip the ISO Plate over so that the boss is on top. Holding the plate over the metatarsal, the apex of the cut should be located at the center of the pocket boss. Step 3 Shift the distal head of the metatarsal laterally as is typically performed in a distal Chevron/Austin osteotomy. A K-wire is recommended to provisionally fix the osteotomy. Note: Ensure the amount of shift is sufficient so that the medial wall of the metatarsal will not interfere with plate insertion. Step 4 Once the desired shift is achieved, place the broach against the flat, cut surface of the metatarsal head. Push the tip of the broach into the proximal metatarsal shaft until the broach contacts the osteotomy site. Make sure to keep the broach parallel to the cut surface of the metatarsal head. If necessary, a mallet can be used to gently tap the broach into place in hard bone. Note: Care must be taken when inserting the broach as this step determines placement and orientation of the plate. Ensure that the broach is inserted flush to the cut surface of the metatarsal head. This will allow for optimal orientation of the plate down the center of the metatarsal shaft. 3
Step 5 Insert the pocket countersink into the micro ratcheting handle. Insert the countersink through the hole in the broach. Drill with the countersink until the shoulder on the countersink hits the shelf inside the broach hole. Remove the countersink. Step 6 With the broach still in place, use the microsagittal saw to resect the residual proximal metatarsal shaft. It is critical not to remove so much bone that the intramedullary part of the plate is destabilized. Remove the broach. Step 7 Select the ISO Plate Inserter Insert and assemble with the ISO Plate inserter as shown. Step 8 Select the ISO Plate from the MINI MAXLOCK EXTREME ISO Caddy and insert the proximal end of the plate into the plate inserter as shown. Insert and rotate the ISO Plate Inserter Threaded Insert clockwise until the plate rests securely in the pocket of the inserter. WARNING: The ISO plate has a sharp leading edge. Step 9 Once the plate is attached to the inserter, push the sharp end of the plate into the slot prepared by the broach. If necessary, a mallet can be used to gently tap the back of the inserter until it makes contact with the distal most portion of the osteotomy on the proximal bone. 4
Step 10 Once the plate is properly positioned, insert the 1.6 mm drill bit provided in the MINI MAXLOCK EXTREME tray through the driver insert to drill a hole for the first 2.4 mm screw. After the hole has been drilled, unscrew the threaded insert from the plate and remove the inserter. Note: A 2.4 mm non-locking screw is recommended for the first screw in order to pull the plate flush against the cut surface of the metatarsal head. If a fixed angle locking screw is used, care must be taken not to move the plate after drilling in order to maintain proper pilot hole alignment and prevent locking screw cross-threading. WARNING: Do not use any other manufacturers screws with the implants. Step 11 Determine the screw length using the provided depth gauge. For all screws used throughout the procedure, verify the screw length using the appropriate gauge on the screw caddy. Using the HEXSTAR Driver, insert the screw. If a locking screw was used, do not fully tighten the screw to the plate until the second locking screw is in place. If a non-locking screw was used, fully tighten the screw. Note: The depth gauge reading corresponds to the working length of the screw (from the distal tip to underneath the screw head). Step 12 Select the 1.6 mm fixed drill guide tip and thread it into the other distal locking hole that has not been drilled. Drill to the desired depth. Repeat Step 11. Fully tighten the screw. 5
Step 13 Attach the ISO pocket drill guide to the drill guide handle, and insert the guide into the pocket. Ensure that the drill guide is fully seated in the pocket hole and that it rests flat against the top surface of the plate. This helps prevent skiving of the drill bit off the inner surface of the lateral cortex. Use the ISO 1.6 mm drill bit to drill to the desired depth. Note: Be sure to select the ISO 1.6 mm drill bit provided in the ISO caddy for this step. Do not use the 1.6 mm drill bit provided in the MINI MAXLOCK EXTREME tray. Note: Only non-locking screws should be used for the pocket hole. If a 2.7 mm non-locking screw is preferred, use the 1.9 mm drill bit to drill to the desired depth. Step 14 Determine the non-locking screw length using the provided depth gauge. Using the HEXSTAR Driver, insert the selected screw. Tighten until sufficient compression across the osteotomy is achieved. Note: In soft bone, over-tightening of the non-locking screw may result in rotation of the plate, changing the intermetatarsal angle. 6
Optional Technique (alternative to Steps 13 and 14) Step 13A Select the ISO pocket guide and place it over the ISO Plate. Use the ISO 1.6 mm drill bit to drill a hole for the 2.4 mm non-locking pocket screw, holding the pocket guide in place to ensure the hole is drilled at the proper angle. Step 14A Remove the ISO pocket guide and determine the screw length using the provided depth gauge. Replace the pocket guide and assemble a 2.4 mm non-locking screw of the desired length onto the HEXSTAR driver. Insert the screw through the pocket guide, tightening until sufficient compression across the osteotomy is achieved. Step 15 Verify final plate and screw placement using fluoroscopy. Step 16 Repair the soft tissues as required by the operative procedure and surgeon preferred technique. Special Note for Removal: To remove the implants at any point during or after the surgery. First, remove all screws. Remove the plate by assembling the three piece plate inserter, threading it into the plate, and tapping the front face of the inserter with a mallet until the plate is removed from the bone. 7
Implants and Instruments PLATES Description Part # ISO Plate MXM-002-EDL- FT ø0.9 mm K-Wire MXM-040-09 Olive Wire MXM-040 ø1.6 mm ISO Drill Bit MXM-072-ISO-16 ISO Plate Inserter MXM-065 ISO Inserter Threaded Insert MXM-065-02 ISO Inserter Insert MXM-065-ISO ISO Pocket Guide MXM-071-ISO Pocket Countersink MXM-074-ISO Plate Broach MXM-085-ISO Pocket Drill Guide Tip MXM-171-ISO 8
SCREWS 2.4 mm Mini Non-Locking Screws Description Part # ø2.4 6 mm Non-locking Screw MXM-011-24-06 ø2.4 8 mm Non-locking Screw MXM-011-24-08 ø2.4 10 mm Non-locking Screw MXM-011-24-10 ø2.4 12 mm Non-locking Screw MXM-011-24-12 ø2.4 14 mm Non-locking Screw MXM-011-24-14 ø2.4 16 mm Non-locking Screw MXM-011-24-16 ø2.4 18 mm Non-locking Screw MXM-011-24-18 ø2.4 20 mm Non-locking Screw MXM-011-24-20 ø2.4 22 mm Non-locking Screw MXM-011-24-22 ø2.4 24 mm Non-locking Screw MXM-011-24-24 ø2.4 26 mm Non-locking Screw MXM-011-24-26 ø2.4 28 mm Non-locking Screw MXM-011-24-28 ø2.4 30 mm Non-locking Screw MXM-011-24-30 ø2.4 35 mm Non-locking Screw MXM-011-24-35 ø2.4 40 mm Non-locking Screw MXM-011-24-40 2.7 mm Mini Non-locking Screws Description Part # ø2.7 6 mm Non-locking Screw MXM-011-27-06 ø2.7 8 mm Non-locking Screw MXM-011-27-08 ø2.7 10 mm Non-locking Screw MXM-011-27-10 ø2.7 12 mm Non-locking Screw MXM-011-27-12 ø2.7 14 mm Non-locking Screw MXM-011-27-14 ø2.7 16 mm Non-locking Screw MXM-011-27-16 ø2.7 18 mm Non-locking Screw MXM-011-27-18 ø2.7 20 mm Non-locking Screw MXM-011-27-20 ø2.7 22 mm Non-locking Screw MXM-011-27-22 ø2.7 24 mm Non-locking Screw MXM-011-27-24 ø2.7 26 mm Non-locking Screw MXM-011-27-26 ø2.7 28 mm Non-locking Screw MXM-011-27-28 ø2.7 30 mm Non-locking Screw MXM-011-27-30 ø2.7 35 mm Non-locking Screw MXM-011-27-35 ø2.7 40 mm Non-locking Screw MXM-011-27-40 9
SCREWS 2.4 mm Fixed Locking Screws Description Part # ø2.4 6 mm Fixed Locking Screw MXM-021-24-06 ø2.4 8 mm Fixed Locking Screw MXM-021-24-08 ø2.4 10 mm Fixed Locking Screw MXM-021-24-10 ø2.4 12 mm Fixed Locking Screw MXM-021-24-12 ø2.4 14 mm Fixed Locking Screw MXM-021-24-14 ø2.4 16 mm Fixed Locking Screw MXM-021-24-16 ø2.4 18 mm Fixed Locking Screw MXM-021-24-18 ø2.4 20 mm Fixed Locking Screw MXM-021-24-20 ø2.4 22 mm Fixed Locking Screw MXM-021-24-22 ø2.4 24 mm Fixed Locking Screw MXM-021-24-24 ø2.4 26 mm Fixed Locking Screw MXM-021-24-26 ø2.4 28 mm Fixed Locking Screw MXM-021-24-28 ø2.4 30 mm Fixed Locking Screw MXM-021-24-30 ø2.4 35 mm Fixed Locking Screw MXM-021-24-35 ø2.4 40 mm Fixed Locking Screw MXM-021-24-40 2.7 mm Fixed Locking Screws Description Part # ø2.7 6 mm Fixed Locking Screw MXM-021-27-06 ø2.7 8 mm Fixed Locking Screw MXM-021-27-08 ø2.7 10 mm Fixed Locking Screw MXM-021-27-10 ø2.7 12 mm Fixed Locking Screw MXM-021-27-12 ø2.7 14 mm Fixed Locking Screw MXM-021-27-14 ø2.7 16 mm Fixed Locking Screw MXM-021-27-16 ø2.7 18 mm Fixed Locking Screw MXM-021-27-18 ø2.7 20 mm Fixed Locking Screw MXM-021-27-20 ø2.7 22 mm Fixed Locking Screw MXM-021-27-22 ø2.7 24 mm Fixed Locking Screw MXM-021-27-24 ø2.7 26 mm Fixed Locking Screw MXM-021-27-26 ø2.7 28 mm Fixed Locking Screw MXM-021-27-28 ø2.7 30 mm Fixed Locking Screw MXM-021-27-30 ø2.7 35 mm Fixed Locking Screw MXM-021-27-35 ø2.7 40 mm Fixed Locking Screw MXM-021-27-40 10
INSTRUMENTS Description Part # ø1.6 mm Drill Bit MXM-072-16 ø1.9 mm Drill Bit MXM-072-19 ø2.7 mm Lag Drill Bit MXM-072-27 Ratcheting Handle HCS-057 Non-Ratcheting Handle HCS-058 Drill Guide Handle MFT-171 HexStar Driver MXM-056T HexStar Driver Break Away MXM-056BA 50 mm Depth Gauge MXM-059-50 Plate Forceps MXM-060 Stagbeetle Forceps MXM-062 Bone Hook MXM-063 Periosteal Elevator MXM-068 ø1.6 mm Fixed Drill Guide MXM-071-16-F ø1.9 mm Fixed Drill Guide MXM-071-19-F ø1.6 mm Centered Drill Guide MXM-171-16-C ø1.6 mm Offset Drill Guide MXM-171-16-O ø1.9 mm Centered Drill Guide MXM-171-19-C ø1.9 mm Offset Drill Guide MXM-171-19-O ø2.7 mm Lag Guide Tip MXM-171-27-C Plate Bending Pliers MXS-051 Baby Hohmann MXS-067 11
1023 Cherry Road Memphis, TN 38117 800 238 7117 901 867 9971 www.wright.com 10801 Nesbitt Avenue South Bloomington, MN 55437 888 867 6437 952 426 7600 www.tornier-us.com Trademarks and Registered marks of Wright Medical Group N.V. or its affiliates. 2016 Wright Medical Group N.V. or its affiliates. All Rights Reserved. MXM 801-002 Rev A ECN 160491 13-Apr-2016