Lag Screw Device Intended for symphyseal fracture fixation of the mandible

Transcription

1 Lag Screw Device Intended for symphyseal fracture fixation of the mandible SUrgicaL TecHNiqUe

2 Lag Screw Device Intended for symphyseal fracture fixation of the mandible Simplifies the lag screw fixation technique by providing accurate placement and measurement of 2.4 mm screws across the fracture site For use with the following items: Universal Trocar Handle [ ] 1.8 mm Insert Drill Guide [ ] 2.4 mm Drill Guide [ ] Supplements the Mandible Modular Fixation System (MMFS); can be stored in the Trocar Tray Insert B [ ] Lag Screw Module for MatrixMANDIBLE TM Plating System Components Lag Screw Cannula [ ] 2.4 mm calibrated cannula with serrated tip works with the Lag Screw Pointer [ ] inserts into the Universal Trocar Handle [ ] couples with the 2.4 mm Drill Guide [ ] and the 1.8 mm Insert Drill Guide [ ] Lag Screw Pointer [ ] calibrated drilling indicator slides along the Lag Screw Cannula to determine drill length Pointer tip predicts exit point at the far cortex easily adjusted and secured in any position with the set screw DePuy Synthes CMF Lag Screw Device Surgical Technique

3 Surgical Technique 1 Reduce the fracture Manipulate the bone fragments until anatomic reduction is achieved. Maintain reduction using bone holding forceps. Bone holding forceps Note: It may be necessary to predrill two holes at the superior portion of the fracture (approximately 1 cm on either side of the fracture) to properly insert the bone holding forceps. Warnings These devices can break during use (when subjected to excessive forces or outside the recommended surgical technique). While the surgeon must make the final decision on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the patient, the broken part should be removed. Instruments and screws may have sharp edges or moving joints that may pinch or tear user s glove or skin. 2 Assemble the Lag Screw Device Insert the Lag Screw Cannula [ ] into the Universal Trocar Handle [ ]. Slide the Lag Screw Pointer [ ] over the cannula and gently secure it by tightening the set screw. Lag Screw Device Surgical Technique DePuy Synthes CMF 2

4 Surgical Technique 3 Drill the gliding hole Insert the 2.4 mm Drill Guide [ ] into the cannula and secure by pressing into place. Place the lag screw device on the mandible perpendicular to the fracture line. Adjust the length and angulation to indicate screw entry and exit points as well as screw length. Precaution: Position the device so that the predetermined drill path avoids tooth roots. Note: To ensure that the lag screw device is positioned properly, the cannula and pointer tips must contact the bone with the drill entry point located approximately 12 mm 15 mm from the fracture. Note the approximate screw length indicated on the scale. Place a long (125 mm) 2.4 mm drill bit through the 2.4 mm Drill Guide [ ] and drill through the near cortex to the fracture line. 3 DePuy Synthes CMF Lag Screw Device Surgical Technique

5 Surgical Technique Precautions: Be sure the drill path avoids the lingual cortex. If the drill exits this cortex, it may bend along the curve of the lingual surface and exit the buccal cortex at a location other than the pointer tip. Drill rate should never exceed 1,800 rpm. Higher rates can result in thermal necrosis of the bone, soft tissue burns, and an oversized hole to be drilled. The adverse effects of an oversized hole include reduced pullout force, increased ease of the screws stripping in bone, and/or suboptimal fixation. Always irrigate during drilling. Avoid drilling over nerve or tooth roots. Take care while drilling as to not damage, entrap, or tear a patient s soft tissue or damage critical structures. Be sure to keep drill clear of loose surgical materials. Handle devices with care and dispose worn bone cutting instruments in a sharps container. 4 Drill the threaded hole Remove the 2.4 mm Drill Guide and replace it with the 1.8 mm Insert Drill Guide [ ]. Seat the drill guide into the drilled hole. Drill with a long (125 mm) 1.8 mm drill bit through the far cortex. Note: The pointer is no longer necessary and may now be removed. Precaution: If using the pointer, be prepared to stop the drill immediately upon contact with the pointer tip. 5 Countersink Use the Countersink [310.80] in the near cortex to allow proper screw head seating. This reduces palpability through the soft tissue Lag Screw Device Surgical Technique DePuy Synthes CMF 4

6 Surgical Technique 6 Measure Confirm screw length using a depth gauge. Note: Due to the anatomy of the anterior mandible, it is necessary to add 2 mm to the reading to ensure that both cortices are engaged. 7 Insert the screw Insert the proper length 2.4 mm self-tapping screw. A second screw is recommended to prevent rotation of the fragments. Repeat the procedure with a second 2.4 mm screw inserted parallel to the first screw. Precaution: Tighten screws in a controlled manner to reduce the risk of stripping. Note: For a complete list of Precautions and Warnings related to the screws, please see the Mandible Modular Fixation System Brochure. 5 DePuy Synthes CMF Lag Screw Device Surgical Technique

7 Lag Screw Device Instruments* Lag Screw Cannula Lag Screw Pointer Supporting Instruments Universal Trocar Handle Bone Reduction Forceps, large Bone Reduction Forceps, small Bone Reduction Forceps, small straight mm Drill Guide mm Drill Bit, quick coupling, 125 mm mm Drill Bit, Stryker J-latch, 125 mm mm Drill Bit, mini quick coupling, 125 mm mm Insert Drill Guide mm Drill Bit, quick coupling, 125 mm mm Drill Bit, Stryker J-latch, 125 mm mm Drill Bit, mini quick coupling, 125 mm countersink with centering pins for 2.4 mm cortex screws Depth Gauge for 2.0 mm and 2.4 mm screws, long Depth Gauge for 2.4 mm screws, long mm Screwdriver, self-retaining mm Screwdriver with holding sleeve For detailed cleaning and sterilization instructions, please refer to: In Canada, the cleaning and sterilization instructions will be provided with the Loaner shipments. * can be stored in the Trocar Tray Insert B [ ] of the Mandible Modular Fixation System. Lag Screw Device Surgical Technique DePuy Synthes CMF 6

8 Limited Warranty and Disclaimer: DePuy Synthes CMF products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. Rx Only Not all products are currently available in all markets. Manufactured by (United States): Synthes CMF 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Legal Manufacturer (Canada): Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) DePuy Synthes CMF, a division of DOI All rights reserved. DSUS/CMF/0714/0152 7/14