Small Plate and Screw System SURGICAL TECHNIQUE

Transcription

1 MINI MAXLOCK EXTREME Small Plate and Screw System SURGICAL TECHNIQUE

2 Contents Key Design Features 2 Surgical Technique 3 Implants and Instruments 9 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. Key Design Features The MINI MAXLOCK EXTREME Plating System with TRIBRID Technology is a comprehensive small plate and screw system intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. The low-profile plates come in a variety of shapes and sizes to meet surgeon preference and patient anatomy. The system offers non-locking, fixed angle locking, and variable angle locking screws to provide fixation without compromise. 2

3 Step 1 Prepare the surgical site. Reduce and temporarily stabilize the fusion or fracture site per the surgeon s preferred technique. Step 2 Select an appropriately sized MINI MAXLOCK EXTREME plate based on the size and type of indication. The plates are available in various lengths and styles. Care must be taken not to scratch or notch the implants throughout the procedure. Note: The MINI MAXLOCK EXTREME implants are designed for smaller anatomies. For larger anatomies or higher load bearing applications, consider using the MAXLOCK EXTREME System. Step 3 If necessary, use the plate bending pliers to contour the plate to the bone surface. Each bend should be in one direction only. Reverse or over bending may cause reduced fatigue life. Avoid excessive bending through the locking holes. If the plate is contoured through the locking holes, a non-locking screw is recommended to avoid cross threading of the fixed angle locking screw or the Mini PEEK Ring. Un-cut mesh plate Note: If using the mesh plate, the plate may be cut to fit the anatomy using the provided plate cutters. When cutting the plate, every locking hole must be linked to at least two other locking holes. Ensure that there are not sharp edges left after cutting the plate. Step 4 Place the plate with at least one hole on one side of the fracture/osteotomy and the other hole(s) on the opposite side of the fracture/osteotomy. When using the plates with compression slots, the slots may be placed on either side of the fracture/osteotomy. Correct plate cut Incorrect plate cut Note: The arrows on the plate indicate the direction of compression. If compression is desired, when placing the plate, be sure to place the plate on the bone with the compression slots oriented in the desired direction. Optional: If desired, the plate may be temporarily held in place with Stagbeetle forceps, k-wires, or olive wires. 3

4 Step 5 The screw holes in the plate are compatible with a variety of screw options. The non-locking 2.0 mm (silver), 2.4 mm (green) and 2.7 mm (magenta) screws can be used with either the locking holes or compression slots. The 2.4 mm (green) and 2.7 mm (magenta) fixed angle locking screws as well as the 2.4 mm (blue) variable angle locking screws (optional) are provided only for the locking holes. Depending on surgeon preference and indication, a combination of 2.0 mm, 2.4 mm and 2.7 mm screws can be used in the plate. Note: Sets are configured to contain either 2.0 mm and 2.4 mm screws or 2.4 mm and 2.7 mm screws. WARNING: Do not use any other manufacturers screws with these implants. Step 6 Color-coded drill bits that correspond with the screws are provided in the system: 1.3 mm (silver), 1.6 mm (green and blue), 1.9 mm (magenta), 2.4 mm (double green) and 2.7 mm (double magenta). The 1.3 mm drill bit is to be used in conjunction with 2.0 mm nonlocking screws; the 1.6 mm drill bit is to be used in conjunction with 2.4 mm non-locking, fixed angle locking, and variable angle locking screws; the 1.9 mm drill bit is to be used in conjunction with the 2.7 mm non-locking and fixed angle locking screws; the 2.4 mm drill bit is to be used to over drill for the lag technique with 2.0 mm and 2.4 mm screws; and the 2.7 mm drill bit is to be used to over drill for the lag technique with the 2.0 mm, 2.4 mm and 2.7 mm screws. Note: Do not under drill for the screws. 4

5 Step 7 When drilling for non-locking screws the centered drill guide tips should be used. The drill guides are color-coded to match the corresponding drill bit and screw diameter. When drilling for fixed angle locking screws, the threaded guides should be used. For variable angle locking screws, the cone drill guide should be used. See Step 9 for variable angle locking technique. When a lag technique is desired, use the double banded drill bit and double banded drill guide tip to over drill the gliding hole. Offset drill guide tips are provided for drilling the pilot hole in the compression slot. See Steps for compression slot technique. Note: To use the drill guide tips, insert the desired guide tip into the handle with the guide hole turned out. Step 8 Drill to the desired depth. Take care not to move the plate after drilling for a locking hole in order to maintain proper pilot hole alignment and prevent fixed angle locking screw cross-threading. Determine the screw length using only the provided depth gauges. In the 2.0 mm/2.4 mm set configuration, two depth gauges are included in the set. They are color-coded to match the drill bit. Note: The depth gauge reading corresponds to the working length of the screw (from the distal tip to underneath the screw head). Step 9 For variable angle locking screws, use the cone drill guide to drill before inserting the Mini PEEK Ring into the plate. (Optional) For the variable angle locking screws, prior to inserting the screw, insert the Mini PEEK Ring, made from PEEK-OPTIMA polymer by Invibio, into the plate. Drive the Mini PEEK Ring until the ring shoulder stops at the top surface of the plate and the driver pops out of the Mini PEEK Ring. The Mini PEEK Ring driver is single use only and should be disposed of. Note: Do not drill through the Mini PEEK Ring. Drill and measure the length prior to inserting the Mini PEEK Ring into the plate. WARNING: Place all non-locking screws (including those in compression slots) before using variable angle screws. 5

6 Step 10 Remove the desired screw from the screw caddy using the corresponding HEXSTAR driver. For non-locking and fixed angle locking screws, use the self-retaining tapered driver. For variable angle locking screws, use the blue banded driver. For all screws used throughout the procedure, verify the screw length using the appropriate gauge on the screw caddy. Note: An optional self-retaining sleeve is available upon request for the variable angle locking driver. Step 11 Use the corresponding HEXSTAR driver to insert the selected screw into the hole and drive the screw. Do not fully tighten the screw to the plate. For variable angle locking screws, stop driving the screw when the bottom of the head hits the top surface of the Mini PEEK Ring. For variable angle locking screws, switch to depth-limiting driver. Step 12 For the variable angle locking screws, use the depth-limiting driver to fully seat the screws. Using the depth limiting driver, drive the screw normal to the top surface of the Mini PEEK Ring, until the driver disengages. The highest point of the screw should sit flush with the top surface of the Mini PEEK Ring. Note: Do not drive the screws too deep. Only drive the screw until the highest point of the screw is flush with the top of the Mini PEEK Ring. Do not use power instruments with the depth limiting driver. Correct driver alignment Incorrect driver alignment WARNING: The variable angle screws may only be inserted into the Mini PEEK Ring once before it must be discarded. 6

7 Step 13 (Optional) In order to generate compression, the plate is first fixed on the side of the fusion site that the arrow is pointing towards (the side opposite the compression slot) using fixed locking screws and/or non-locking screws through a locking hole. Once all screws on the one side are in place, fully tighten them. Step 14 Select the appropriate drill bit and offset drill guide tip for the desired non-locking screw size. Insert the offset drill guide into the compression slot with the arrow on the drill guide oriented in the same direction as the arrow on the plate. Insert the appropriate drill bit through the drill guide and drill to the desired depth. The hole may go through one or both of the cortices. Correct orientation Incorrect orientation Note: Only non-locking screws may be used in the compression slot. Drill for compression screw Step 15 Insert the screw into the hole and drive the screw into the plate. Fully seat the screw to the plate to generate compression. Start position Finish position 7

8 Step 16 Fill all remaining screw holes as desired. Step 17 Completely tighten all remaining screws. During final tightening, take caution to not over torque the screws. Step 18 Verify the correct placement of the fixation device. Step 19 Replace the soft tissues as required by the operative procedure and surgeon preferred technique. Special Note: For removal of the Mini PEEK Ring, use the provided Mini PEEK Ring removal tool. After removing the screw, insert the removal tool into the Mini PEEK Ring and rotate counter-clockwise. The Mini PEEK Ring is no longer usable and should be disposed of. 8

9 Implants and Instruments PLATES Description Part # 2-Hole Flat T-Plate 4-Hole Flat T-Plate H-Plate 2-Hole Locking OrthoLink Plate 2-Hole OrthoLink Plate 3-Hole OrthoLink Plate 4-Hole OrthoLink Plate 6-Hole OrthoLink Plate 2-Hole Alpha Y-Plate 2-Hole Beta Y-Plate 4-Hole Alpha Y-Plate 4-Hole Beta Y-Plate 1-Hole Universal Plate 2-Hole Universal Plate 4-Hole Universal Plate MXM-002-2T MXM-002-4T MXM-002-H MXM-002-2PLKG MXM-002-2P MXM-002-3P MXM-002-4P MXM-002-6P MXM-002-2YA MXM-002-2YB MXM-002-4YA MXM-002-4YB MXM-002-1A MXM-002-2A MXM-002-4A ø0.9 mm K-Wire MXM Olive Wire MXM-040 Optional 3-Hole T-Plate 5-Hole OrthoLink Plate MXM-002-3T MXM-002-5P 17-Hole Mesh Plate MXM M ø2.4 mm Ring/Driver Assm. VAR ø2.4 mm Depth Limiting Driver VAR ø2.4 mm Depth Limiting Driver Tip VAR R HEXSTAR Driver VAR H ø1.6 mm Variable Drill Guide VAR F ø2.4 mm Ring Removal Tool VAR ø2.4 mm Variable Angle Locking Self Retaining Driver Sleeve VAR SR 9

10 SCREWS 2.0 mm Non-Locking Screws Description Part # ø2.0 mm 6mm Non-Locking Screw MXM ø2.0 mm 8 mm Non-Locking Screw MXM ø2.0 mm 10 mm Non-Locking Screw MXM ø2.0 mm 12 mm Non-Locking Screw MXM ø2.0 mm 14 mm Non-Locking Screw MXM ø2.0 mm 16 mm Non-Locking Screw MXM ø2.0 mm 18 mm Non-Locking Screw MXM ø2.0 mm 20 mm Non-Locking Screw MXM ø2.0 mm 22 mm Non-Locking Screw MXM ø2.0 mm 24 mm Non-Locking Screw MXM ø2.0 mm 26 mm Non-Locking Screw MXM ø2.0 mm 28 mm Non-Locking Screw MXM ø2.0 mm 30 mm Non-Locking Screw MXM mm Non-Locking Screws Description Part # ø2.4 6 mm Non-locking Screw MXM ø2.4 8 mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM

11 SCREWS 2.7 mm Non-locking Screws Description Part # ø2.7 6 mm Non-locking Screw MXM ø2.7 8 mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM ø mm Non-locking Screw MXM

12 SCREWS 2.4 mm Fixed Locking Screws Description Part # ø2.4 6 mm Fixed Locking Screw MXM ø2.4 8 mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM mm Fixed Locking Screws Description Part # ø2.7 6 mm Fixed Locking Screw MXM ø2.7 8 mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM ø mm Fixed Locking Screw MXM

13 SCREWS 2.4 mm Mini Variable Angle Screws Description Part # ø2.4 6 mm Variable Angle Screw VAR ø2.4 8 mm Variable Angle Screw VAR ø mm Variable Angle Screw VAR ø mm Variable Angle Screw VAR ø mm Variable Angle Screw VAR ø mm Variable Angle Screw VAR ø mm Variable Angle Screw VAR ø mm Variable Angle Screw VAR ø mm Variable Angle Screw VAR ø mm Variable Angle Screw VAR ø mm Variable Angle Screw VAR ø mm Variable Angle Screw VAR ø mm Variable Angle Screw VAR

14 INSTRUMENTS Description Part # ø1.3 mm Drill Bit MXM ø1.6 mm Drill Bit MXM ø1.9 mm Drill Bit MXM ø2.4 mm Lag Drill Bit MXM ø2.7 mm Lag Drill Bit MXM 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 Plate Forceps MXM-060 Stagbeetle Forceps MXM-062 Bone Hook MXM-063 Periosteal Elevator MXM-068 ø1.3 mm Centered Drill Guide MXM C ø1.3 mm Offset Drill Guide MXM O ø1.6 mm Fixed Drill Guide MXM F ø1.9 mm Fixed Drill Guide MXM F ø1.6 mm Centered Drill Guide MXM C ø1.6 mm Offset Drill Guide MXM O ø1.9 mm Centered Drill Guide MXM C ø1.9 mm Offset Drill Guide MXM O ø2.4 mm Centered Drill Guide MXM C ø2.7 mm Lag Guide Tip MXM C Plate Bending Pliers MXS-051 Baby Hohmann MXS

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16 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. MXM Rev A ECN Apr-2016