Dynamic Locking Screw (DLS) System. For use with locking compression plate (LCP) systems. Technique Guide Table of Contents Introduction Surgical Technique Product Information Dynamic Locking Screw (DLS) System 2 Locking Compression Plate (LCP) 4 AO Principles 5 Indications and Contraindications 6 Preparation 7 Dynamic Locking Screw Technique 8 Implant Removal 13 Implants 14 Instruments – for 3.7 mm DLS Screws – for 5.0 mm DLS Screws 15 16 Set Lists 18 Image intensiļ¬er control Dynamic Locking Screw System Technique Guide Synthes Dynamic Locking Screw (DLS) System. For use with locking compression plate (LCP) systems. Features Angular stable screw Locking screws can be placed in each threaded hole of the appropriate LCP plate. StarDrive recess for improved torque transmission*. Screws locking tightly in the plate are designed to: – aid in minimizing tension on the bone – aid in minimizing compression between plate and bone – aid in protecting the periosteum from potential damage and retain circulation Pin-sleeve design of the DLS allows micro-motion within the angular stable system. Cobalt chromium molybdenum alloy (CoCrMo) enables DLS to be used with all Synthes stainless steel or titanium locking large and small fragment plates. Laserwelded. For stable fixation between pin and sleeve. *Testing on file at Synthes. 2 Synthes Dynamic Locking Screw System Technique Guide Principle of Dynamic Locking Screw (DLS) Standard locking head. Compatible with all Synthes large and small fragment locking plates. DLS allows surgeons to modulate the rigidity of the locking plate construct. Pin-sleeve design. Micro-motion within the screw. DLS construct can deliver nearly parallel fracture site motion. Fully threaded shaft. With locking screw profile. New screw tip. Rounded tip with self-tapping flute design. Dynamic Locking Screw System Technique Guide Synthes 3 Locking Compression Plate (LCP) The Synthes Locking Compression Plate: – Provides angular stable support of fragments regardless of bone quality – Is designed to reduce risk of primary and secondary loss of reduction even under high dynamic loading – Is designed to reduce impairment of periosteal blood supply due to limited plate-periosteum contact – Is designed to maintain a favorable hold in osteoporotic bone and multiple fragment fractures Locking Compression Plates have combination locking and compression holes (Combi holes). The Combi holes allow placement of standard cortex and cancellous bone screws on one side or threaded conical locking screws on the opposite side of each hole. a. Threaded hole section for locking screws b. Dynamic compression unit (DCU) hole section for standard screws c. Locking screw in threaded side of plate hole d. Cortex screw in compression side of plate hole d c a b Note: Holes in straight and reconstruction plates are oriented so that the compression component of the hole is always directed toward the middle of the plate. 4 Synthes Dynamic Locking Screw System Technique Guide AO Principles In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.1 They are: Anatomic reduction Fracture reduction and fixation to restore anatomical relationships. Stable fixation Stability by fixation or splintage, as the personality of the fracture and injury requires. Preservation of blood supply Preservation of the blood supply to soft tissue and bone by careful handling. Early, active mobilization Early and safe mobilization of the part and the patient. 1. M.E. Muller, M. Allgöwer, R. Schneider, and H. Willenegger: Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991. Dynamic Locking Screw System Technique Guide Synthes 5 Indications and Contraindications Indications Synthes Dynamic Locking Screws (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of nonunions and malunions. Contraindications – Severe muscular, neural or vascular diseases that endanger the extremities involved – Lack of bone substance or poor bone quality which makes stable seating of the implant impossible – Acute or chronic, local or systemic infections, and allergy to the implanted material The Synthes Dynamic Locking Screws are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The adverse events that could occur are infection*, cardiovascular disorder*, hematoma*, malunion or nonunion. * These risks can also be associated with general risks of surgery. 6 Synthes Dynamic Locking Screw System Technique Guide Preparation Synthes offers a wide selection of LCP plates, which cover a variety of indications. For this reason, this technique guide does not cover specific indications or the selection of a plate type for specific clinical situations. For these subjects, please refer to “AO Principles of Fracture Management” courses offered by the AO Foundation (www.aofoundation.org), and the corresponding professional literature. For general purposes, the following techniques for handling the implants and instruments will be demonstrated with a straight 3.5 mm LCP plate and 3.7 mm DLS. Important: The 3.7 mm DLS has a 0.2 mm larger diameter compared to the standard 3.5 mm locking screw. Therefore, dedicated instruments for 3.7 mm DLS (drill bit and drill sleeve) have to be used. All other instruments are the same as standard locking small fragment technique. Note: The 5.0 mm DLS is inserted per standard 5.0 mm locking screw technique. Required sets are dependent on the plates used. For small fragment plates: 105.434 Small Fragment LCP Instrument and Implant Set, with self-tapping screws or 145.434 Small Fragment LCP Instrument and Titanium Implant Set, with self-tapping screws or 01.212.005 Small Fragment LCP Instrument and Implant Set, with 3.5 mm StarDrive Cortex Screws or 01.212.006 Small Fragment LCP Instrument and Implant Set, with 3.5 mm Hex Drive Cortex Screws or 01.212.007 Small Fragment LCP Instrument and Implant Set, with 4.0 mm Cannulated Screws or 01.212.008 Small Fragment LCP Instrument and Titanium Implant Set, with 3.5 mm StarDrive Cortex Screws or 01.212.009 Small Fragment LCP Instrument and Titanium Implant Set, with 3.5 mm Hex Drive Cortex Screws and 01.213.003 3.7 mm DLS Instrument Set Note: The 3.7 mm DLS requires the use of: 03.213.001 3.1 mm Drill Guide, for 3.7 mm Dynamic Locking Screw and 03.213.002 3.1 mm Drill Bit, quick coupling, 165 mm length, for 3.7 mm Dynamic Locking Screw Do not insert the 3.7 mm DLS using the 2.8 mm Drill Bit used for 3.5 mm Locking Screws. Dynamic Locking Screw System Technique Guide Synthes 7 Dynamic Locking Screw Technique 1 Reduce fracture Reduce the fracture under image intensification and, as needed, provide fixation with a Kirschner wire or reduction forceps. 2 Contour plate Instruments 329.04 Bending Iron, for 2.7 mm and 3.5 mm plates, 150 mm length (for use with 329.05) 329.05 Bending Iron, for 2.7 mm and 3.5 mm plates, 150 mm length (for use with 329.04) 329.15 Bending Pliers, for 2.7 mm and 3.5 mm plates, 230 mm length 329.29 Bending Pliers, for 2.7 mm and 3.5 mm Reconstruction Plates, 246 mm length Adapt the LCP plate to the anatomy using the appropriate bending instruments (as for standard plates). Note: The LCP Combi holes are asymmetrical in the plate. In straight plates, the hole alignment changes in the middle of the plate. This asymmetry enables exertion of unidirectional dynamic compression. 8 Synthes Dynamic Locking Screw System Technique Guide Dynamic Locking Screw Technique 3 Position plate Position and fix the plate on the bone. Important: Before setting the first dynamic locking screw, verify that the plate is provisionally fixed in place. Otherwise, the plate may rotate during final tightening and cause damage to surrounding soft tissue. 4 Insert DLS drill sleeve Instrument 03.213.001 3.1 mm Drill Guide, for 3.7 mm Dynamic Locking Screw Carefully thread the drill guide into the desired LCP hole until it is secure. The drill sleeve ensures that the DLS is correctly aligned with the locking hole in the plate. Angular stability is reduced if a locking screw is inserted obliquely. Technique tip: If alignment is difficult, it may be useful to slightly rotate the drill sleeve counterclockwise. Note: In precontoured plates, the threaded hole is typically not perpendicular to the plate surface due to the anatomy. Important: Only use the white color-coded DLS drill guide with the white color-coded drill bit for 3.7 mm DLS. The 5.0 mm DLS uses the same instruments as the 5.0 mm LCP. Dynamic Locking Screw System Technique Guide Synthes 9 Dynamic Locking Screw Technique 5 Predrill screw hole Instrument 03.213.002 3.1 mm Drill Bit, quick coupling, 165 mm length, for 3.7 mm Dynamic Locking Screw Carefully drill the screw hole using an appropriate drill. Remove the drill sleeve. Important: Only use the white color-coded DLS drill bit to ensure the correct drill hole. 6 Determine screw length Instrument 319.01 Depth Gauge Determine screw length with the depth gauge. 10 Synthes Dynamic Locking Screw System Technique Guide 7 Insert Dynamic Locking Screw Instruments 311.43 Handle, with quick coupling 314.116 StarDrive Screwdriver Shaft, T15, self-retaining, quick coupling 511.773 Torque Limiting Attachment, 1.5 Nm, quick coupling Prior to insertion of the first DLS, anatomical reconstruction must have occurred. After insertion of the DLS, additional reduction can no longer occur without removing the DLS. The DLS can either be inserted with power (without final locking) or manually. Technique tip: To ease insertion into very hard bone, the DLS can be turned counterclockwise a few turns and reinserted. Important: Always insert the DLS with the appropriate Torque Limiting Attachment (TLA). Three or more dynamic locking screws must be inserted for each segment / fragment. Do not combine standard locking screws and / or standard cortex screws with DLS in the same segment / fragment. This will nullify the dynamization and overload the standard locking screw; however, one fragment can be fixed with all standard locking screws and another with all DLS. Dynamic Locking Screw System Technique Guide Synthes 11 Dynamic Locking Screw Technique 7a Screw insertion with power To insert the DLS using power, attach the appropriate TLA to the power tool. Insert the screwdriver shaft into the TLA. Pick up the DLS and insert it into the plate hole. To insert the screw, start the power tool slowly, increasing speed and then reducing it again before the screw is fully tightened. Uncouple the power tool and mount the appropriate handle to manually tighten the screw. After one click, the optimum torque is reached. Notes: DLS should be inserted under power using the TLA. After the screw insertion using the TLA, always hand tighten to ensure the screws are fully inserted For long screws and thick cortical bone, ensure sufficient cooling during insertion Important: Insert the DLS with the appropriate TLA: – For 3.7 mm DLS screws, use the 1.5 Nm TLA – For 5.0 mm DLS screws, use the 4.0 Nm TLA 7b Manual insertion For manual DLS insertion, attach the handle to the TLA and insert a screwdriver shaft. Insert the DLS, and lock it in the plate. Important: Insert the DLS with the appropriate TLA: – For 3.7 mm DLS screws, use the 1.5 Nm TLA – For 5.0 mm DLS screws, use the 4.0 Nm TLA 12 Synthes Dynamic Locking Screw System Technique Guide Implant Removal To remove the plate, first remove tissue and bone from all screw heads and drive recesses. Insert a screwdriver in the screw recess and unlock all screws manually. Then, completely remove all of the screws. Dynamic Locking Screw System Technique Guide Synthes 13 Implants 3.7 mm Dynamic Locking Screws, self-tapping – CoCrMo – Sterile Length Length (mm) (mm) 09.213.022S 22 09.213.044S 44 09.213.024S 24 09.213.046S 46 09.213.026S 26 09.213.048S 48 09.213.028S 28 09.213.050S 50 09.213.030S 30 09.213.052S 52 09.213.032S 32 09.213.054S 54 09.213.034S 34 09.213.056S 56 09.213.036S 36 09.213.058S 58 09.213.038S 38 09.213.060S 60 09.213.040S 40 09.213.065S 65 09.213.042S 42 09.213.070S 70 5.0 mm Dynamic Locking Screws, self-tapping – CoCrMo – Sterile Length Length (mm) (mm) 09.223.032S 32 09.223.050S 50 09.223.034S 34 09.223.055S 55 09.223.036S 36 09.223.060S 60 09.223.038S 38 09.223.065S 65 09.223.040S 40 09.223.070S 70 09.223.042S 42 09.223.075S 75 09.223.044S 44 09.223.080S 80 09.223.046S 46 09.223.085S 85 09.223.048S 48 09.223.090S 90 Warning: Do not resterilize dynamic locking screws. 14 Synthes Dynamic Locking Screw System Technique Guide Instruments for use with 3.7 mm Dynamic Locking Screws (DLS) 03.213.001 3.1 mm Drill Guide, for 3.7 mm Dynamic Locking Screw 03.213.002 3.1 mm Drill Bit, quick coupling, 165 mm length, for 3.7 mm Dynamic Locking Screw 311.43* Handle, with quick coupling 314.116* StarDrive Screwdriver Shaft, T15, self-retaining, quick coupling 319.01* Depth Gauge 329.04* Bending Iron, for 2.7 mm to 3.5 mm plates, 150 mm length (for use with 329.05) 329.05* Bending Iron, for 2.7 mm to 3.5 mm plates, 150 mm length (for use with 329.04) 511.773* Torque Limiting Attachment, 1.5 Nm, quick coupling * All instruments are found in Synthes Small Fragment LCP Sets (105.434, 145.434, 01.212.005, 01.212.006, 01.212.007, 01.212.008, 01.212.009) Dynamic Locking Screw System Technique Guide Synthes 15 Instruments for use with 5.0 mm Dynamic Locking Screws* 310.431 4.3 mm Drill Bit, quick coupling, 180 mm 312.449 4.3 mm Threaded Drill Guide 314.11 Holding Sleeve, 121 mm 314.118 StarDrive Screwdriver, T25, self-retaining, 245 mm 314.119 StarDrive Screwdriver Shaft, T25 self-retaining, quick coupling, 165 mm 323.021 Direct Measuring Device * All instruments are found in Synthes Large Fragment LCP Sets (115.400, 146.400, 115.401, 115.405, 146.405) 16 Synthes Dynamic Locking Screw System Technique Guide 323.46 4.5 mm Universal Drill Guide 397.706 Handle, for AO Reaming Coupler Connection 511.774 Torque Limiting Attachment, 4 Nm, for AO Reaming Coupler Dynamic Locking Screw System Technique Guide Synthes 17 3.7 mm and 5.0 mm Dynamic Locking Screw Set (01.213.006) Module and Case 60.213.001 3.7 mm Dynamic Locking Screw Instrument Module 60.213.002 Instruments 03.213.001 03.213.002 Case for 3.7 mm and 5.0 mm Dynamic Locking Screws 3.1 mm Drill Guide, for 3.7 mm Dynamic Locking Screw, 2 ea. 3.1 mm Drill Bit, quick coupling, 165 mm length, for 3.7 mm Dynamic Locking Screw, 2 ea. Implants 3.7 mm Dynamic Locking Screws, self-tapping, 4 ea. Length (mm) Length (mm) 09.213.022S 22 09.213.044S 44 09.213.024S 24 09.213.046S 46 09.213.026S 26 09.213.048S 48 09.213.028S 28 09.213.050S 50 09.213.030S 30 09.213.052S 52 09.213.032S 32 09.213.054S 54 09.213.034S 34 09.213.056S 56 09.213.036S 36 09.213.058S 58 09.213.038S 38 09.213.060S 60 09.213.040S 40 09.213.065S 65 09.213.042S 42 09.213.070S 70 5.0 mm Dynamic Locking Screws, self-tapping, 4 ea. Length (mm) 09.223.032S 32 09.223.050S 50 09.223.034S 34 09.223.055S 55 09.223.036S 36 09.223.060S 60 09.223.038S 38 09.223.065S 65 09.223.040S 40 09.223.070S 70 09.223.042S 42 09.223.075S 75 09.223.044S 44 09.223.080S 80 09.223.046S 46 09.223.085S 85 09.223.048S 48 09.223.090S 90 Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to http://www.synthes.com/sites/NA/MedicalCommunity/Pages/Cleaning_and_Sterilization.aspx or to the below listed inserts, which will be included in the shipping container: – Processing Synthes Reusable Medical Devices - Instruments, Instrument Trays and Graphic Cases — DJ1305 – Processing Non-sterile Synthes Implants — DJ1304 18 Synthes Dynamic Locking Screw System Technique Guide Length (mm) 3.7 mm Dynamic Locking Screw Instrument Set (01.213.003) Module 60.213.001 Instruments 03.213.001 03.213.002 Also Available 60.212.006 3.7 mm Dynamic Locking Screw Instrument Module 3.1 mm Drill Guide, for 3.7 mm Dynamic Locking Screw, 2 ea. 3.1 mm Drill Bit, quick coupling, 165 mm length, for 3.7 mm Dynamic Locking Screw, 2 ea. 60.213.001 Instrument Tray, for LCP Small Fragment Instrument and Implant Set Dynamic Locking Screw System Technique Guide Synthes 19 Synthes USA 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 © 2011 Synthes, Inc. or its affiliates. All rights reserved. Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 Combi, LCP and Synthes are trademarks of Synthes, Inc. or its affiliates. www.synthes.com Printed in U.S.A. 1/12 J10966-A