MaxTorque. surgical technique. Cannulated Screw System. Foot & Ankle. OrthoHelix Technology

Transcription

1 MaxTorque Cannulated Screw System OrthoHelix Technology surgical technique Foot & Ankle

2 2 M A X T O R Q U E C A N N U L A T E D S C R E W S Y S T E M

3 Table of Contents Advantages 3 Indications 4 Contraindications 4 Key Features 5 Surgical Technique 6 Implants and Instruments 10 Advantages Spherical Head Design Reduces the chance of soft tissue irritation and stress risers Self-Tapping and Self-Drilling Options Reduce steps and time in the OR Reverse Cutting Flutes Assist in screw removal HexStar Drive Feature Reduces stripping during screw insertion/removal Hybrid Screw Thread Increased pullout strength 3

4 Indications The MaxTorque and Mini MaxTorque Screw Systems are indicated for use in long and small bone fracture, fusion, and osteotomy fixation, which includes but is not limited to the following: Fractures of the tarsal and metatarsals Fractures of the olecranon, distal humerus Fractures of the radius and ulna Patellar fractures Distal tibia and pilon fractures Fractures of the fibula, medial malleolus, os calcis Tarso-metatarsal and metatarsal-phalangeal arthrodesis Metatarsal and phalangeal osteotomies Osteochondritis dissecans Ligament fixation Other small fragment, cancellous bone fractures and osteotomies Contraindications Cases where there is an active infection Cases with malignant primary or metastasis tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized. Conditions which tend to retard healing, such as blood supply limitations, previous infections, etc. Insufficient quantity or quality of bone to permit stabilization of the fracture complex. Conditions that restrict the patient s ability or willingness to follow post-operative instructions during the healing process Foreign body sensitivity where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation Cases where the patient is obese. 4

5 Key Features The MaxTorque Cannulated Screw System is a comprehensive set of implantable bone fixation screws intended for use in long and small bone fracture, fusion, and osteotomy fixation. The screws come in a variety of diameters, screw lengths, and thread lengths to address a wide variety of patient anatomies and surgical procedures. The screws include self-drilling tips and self-tapping threads for ease of insertion as well as reverse cutting flutes for ease of removal. Optional blunt-tipped screws are available if reduction in tendon irritation is desired. Their unique thread design offers better bone purchase and significantly increases pull out strength compared to other cannulated screws. The screws are manufactured from a Titanium alloy (Ti-6Al-4V), which is a biocompatible material that allows for a color coded, user friendly system. IMPLANT AND SCREW SIZES INSTRUMENT COLOR DIAMETER AVAILABLE LENGTHS Gold ø4.0 mm 14 mm 50 mm Green ø5.5 mm 26 mm 70 mm Blue ø7.0 mm 40 mm 130 mm A pullout out test was conducted with the two market leaders of large cannulated screws. The test was replicated with seven distinct trials and each time the MaxTorque screw beat the competition. The data indicated that the pull-out strength of the MaxTorque screw is 57% better than one market leader and 46% better than another. Due to the unique thread design of the MaxTorque screw, the pull-out strength tested significantly better than the other two screws. All three screws tested were manufactured from Titanium Alloy and were either 7.0 mm or 7.3 mm in outer diameter. This study was performed by an independent testing lab. 180% Cannulated Screw Pull-Out Strength Comparison Percentage of Maximum Load (Normalized to Market Leader 2) 160% 140% 120% 100% 80% 60% 40% 20% 157% 108% 100% 0% MaxTorque Market Leader 1 Market Leader 2 Testing followed the ASTM Standard F543-02, Standard Specification and Test Methods for Metallic Medical Bone Screws. The following Annexes were utilized: A3. Test Method for Determining the Axial Pullout Strength of Medical Bone Screws. 5

6 Surgical Technique Step 1 The surgical site is exposed and prepared for fixation utilizing the surgeon s preferred technique. Guide wires or other methods may be used for temporary stabilization of the bone as needed. Step 2 Based on preference, bone size, location and indication, choose between the ø4.0 mm (gold), ø5.5 mm (green) and ø7.0 mm (blue) cannulated screws. Screws, washers and instruments are color-coded by size for ease of use. Step 3 Once a screw diameter has been chosen, select the corresponding guide wire and use a wire driver to insert the guide wire to the desired final screw position. Use the corresponding wire insertion guide, assembled by sliding into the corresponding drill guide, to aid in directing the wire and to prevent injury to the adjacent soft tissues. Verify guide wire placement using fluoroscopy. SCREW SIZE GUIDE WIRE SIZE DRILL BIT SIZE ø4.0 mm ø1.4 mm ø2.7 mm ø5.5 mm ø1.9 mm ø3.7 mm ø7.0 mm ø2.3 mm ø4.7 mm Note: It is helpful to verify correct guide wire placement in at least two planes under fluoroscopy. Additional oblique views may be helpful to visualize wire depth, proximity to adjacent joints, and to insure that there will be enough bone on the threaded end of the screw to allow for effective compression by the partially threaded lag screw. Note: Guide wires are available in both smooth and threaded tip depending on surgeon preference. 6

7 Step 4 Use the corresponding depth gauge to measure screw length required. Note: The depth gauge reading corresponds to the working length of the screw (from distal tip to underneath the screw head). If planning to fully countersink the screw, subtract 3.5 mm for ø4.0 mm screws, 4.0 mm for ø5.5 mm screws or 4.5 mm for ø7.0 mm screws from the depth gauge reading. Note: Consider the amount of compression to be generated when selecting a screw length. A shorter screw may be required. Note: For all screws used throughout procedure, verify screw length using the appropriate gauge on the screw caddy. Step 5 Remove the wire insertion sleeve from the drill guide. With the appropriate cannulated drill bit, and using the drill guide to help protect the surrounding soft tissue, drill over the guide wire to the desired depth. Note: The depth markings on the drill bits apply only when used with a drill guide Note: MaxTorque screws feature a sharp tip. Due to the self-drilling tip, the use of the cannulated drill is optional. However, due to the superior thread depth of MaxTorque screws, it is recommended to use the cannulated drill to breach the near cortex and drill across any sclerotic bone surfaces to make screw insertion easier and prevent distraction at the fusion/fracture site. Care should be taken so that the screw tip does not penetrate the far cortex, as the self-drilling tip might cause soft tissue irritation. 7

8 OPTIONAL STEPS Step 6 To countersink the screw, place the corresponding sized countersink instrument into the screw driver handle and slip it over the guide wire. Use the countersink to remove enough cortical bone to allow seating of the screw head. Note: Removing too much bone will cause loss of screw head purchase which would diminish the compression lag effect of the screw. Note: Use ø4.0 mm countersink with the flat-sided quick connect (AO connection) driver handle and ø5.5 mm and ø7.0 mm countersinks with square connection driver handle. Make sure that countersinking is done after the hole is drilled. Step 7 Although MaxTorque screws are self-tapping, hand taps are included in the set if desired. It is recommended to tap by hand and not under power. Step 8 If necessary, a washer may be used to improve the compression lag effect in soft bone. Choose a corresponding sized washer and slip over the screw prior to insertion, be sure the logo is facing up. It is not recommended to bend the washers. Note: Tighten screw into washer implementing the standard two finger finishing technique. Do not overtighten screws into washer. 8

9 Step 9 Insert the cannulated screw into the bone over the guide wire. Drive the screw clockwise into the bone until the desired depth and compression of the screw is achieved. Hold compression across the fusion site as the screw is advanced in order to prevent distraction by the screws. Note: Use ø4.0 mm driver with the flat-sided quick connect (AO connection) handle and ø5.5 mm and ø7.0 drivers with square connection handle. If power is desired to drive the screws, use an AO adapter (not included) for the ø4.0 mm driver. Use a 3-Jaw Jacob s Chuck for the ø5.5 mm and ø7.0 mm drivers and tighten the jaws onto the faces identified with a black dot. Step 10 Remove guide wire(s) with the power wire driver in reverse (counter-clockwise direction). Step 11 Verify correct placement of the screw(s) with fluoroscopy in at least two planes and use multiple oblique views as needed to insure proper location of the implanted screws prior to wound closure. Note: Avoid placing additional screws such that the screw threads contact each other during screw insertion as this may cause damage to the threads. Step 12 Repair soft tissues as required by the surgical procedure. Warning: Do not use other manufacturers instruments or implants in conjunction with the MaxTorque Cannulated Screw System. 9

10 Implants and Instruments IMPLANTS Screws Description Part # MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L 10

11 IMPLANTS Screws Description Part # MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L 11

12 IMPLANTS Screws Description Part # MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Short Thread Screw MSD S MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L MaxTorque Self-Drilling Cannulated ø mm Long Thread Screw MSD L 12

13 IMPLANTS Screws Description Part # MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P MaxTorque Self-Drilling Cannulated ø mm Petite Thread Screw MSD P ADDITIONAL OPTIONS Description Part # MaxTorque Blunt Tip Cannulated Screws (available in all standard MSD lengths) CSS-011-XX-XXXX MaxTorque Fully Threaded Cannulated Screws (40 mm-130 mm) SP-MSD-70-XXXF MaxTorque Extended Length Cannulated ø4.0 Screws (55 mm-70 mm) *MSD XXXX *Extended Length instrumentation MaxTorque Extended Length Cannulated ø5.5 Screws (75 mm-100 mm) *MSD XXXX available upon request Washers Description Part # MaxTorque ø4.0 mm Flat Washer CSS A MaxTorque ø4.0 mm Domed Washer CSS B MaxTorque ø5.5 mm Flat Washer CSS A MaxTorque ø5.5 mm Domed Washer CSS B MaxTorque ø7.0 mm Flat Washer CSS A MaxTorque ø7.0 mm Domed Washer CSS B 13

14 INSTRUMENTS Description Part # MaxTorque 4.0 Countersink CSS MaxTorque 5.5 Countersink CSS MaxTorque 7.0 Countersink CSS MaxTorque 2.7 Drill Bit CSS MaxTorque 3.7 Drill Bit w/ 1/4 Square Connect CSS SQ MaxTorque 4.7 Drill Bit w/ 1/4 Square Connect CSS SQ ø 1.4 mm Guide-wire CSS ø 1.4 mm Threaded Guide-wire CSS T ø 1.9 mm Guide-wire CSS ø 1.9 mm Threaded Guide-wire CSS T ø 2.3 mm Guide-wire CSS ø 2.3 mm Threaded Guide-wire CSS T 14

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16 US HEADQUARTERS Tornier, Inc Nesbitt Avenue South Bloomington, MN USA INTERNATIONAL HEADQUARTERS Tornier SAS 161 rue Lavoisier Montbonnot Saint Martin France + 33 (0) Prior to using any Tornier device, please review the instructions for use and surgical technique for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use Tornier, Inc. All rights reserved. Tornier and are trademarks or registered trademarks of Tornier in the U.S. and other countries. HexStar and MaxTorque are trademarks or registered trademarks of OrthoHelix Surgical Designs, Inc. in the U.S. and other countries. MSD REV A ECN /15