Gamma3 U-Blade Lag Screw - OTC Switzerland

1 Gamma3 . U-Blade Lag Screw Operative Technique Hip Fracture Gamma3 System Contributing Surgeons: Prof. Kwok Sui Leung, M. D. Chairman of Department of Orthopaedics and Traumatology The Chinese University of Hong Kong Prince of Wales Hospital Hong Kong Asst. Prof. Gilbert Taglang, M. D. Department of Traumatology University Hospital, Strasbourg France Prof. Dr. med. Volker B hren Chief of Surgical Services Medical Director of Murnau Trauma Center, Murnau Germany Katsumi Sato M. D. Ph. D. Vice-Director, Chief Surgeon Tohoku University Graduate School of Medicine Tohoku Rosai Hospital, Sendai Japan Christopher T. Born, M. D. Professor of Orthopaedic Surgery Department of Orthopaedic Trauma Brown University School of Medicine Providence, Rhode Island USA.

2 Robert Probe, M. D. Chairman - Department of Orthopaedic Surgery Scott & White Memorial Hospital, Temple, Tx USA. Prof. Dr. med. Vilmos V csei Chief of Traumatology Department University of Vienna, Vienna Austria Acknowledgements: Our thanks are due to the many surgeons who supported the development of the Gamma3 System, with their feedback and ideas, during worldwide panel meetings and helped the Gamma3 . System to be what it is today. Special thanks to Karich Head of the Trauma Department Heinrich-Braun-Hospital, Zwickau Germany and all surgeons, who supported the idea of the U-Blade Lag Screw for the treatment of proximal femur fractures. 2. Contents Page 1. Features and Benefits 4. Gamma3 U-Blade Lag Screw Set 4. 2. Indications & Contraindications 5.

3 3. Operative Technique 6. Gamma3 U-Blade Lag Screw Placement 6. Gamma3 U-Blade Lag Screw Insertion 8. Gamma3 U-Blade Lag Screw fixation 9. Gamma3 U-Blade Insertion 10. Extraction of the Gamma3 U-Blade Lag Screw 15. Ordering Information Instruments 18. Ordering Information Implants 19. This publication sets forth detailed recommended procedures for using Stryker Osteosynthesis devices and instruments. It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required. A workshop training is required prior to first surgery. See package insert (L22000007) for a complete list of potential adverse effects, contraindications, warnings and precautions.

4 The surgeon must discuss all relevant risks, including the finite lifetime of the device, with the patient, when necessary. Warning: All bone screws referenced in this brochure are not approved for Screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. 3. Features & Benefits The Gamma3 U-Blade Lag Screw Set Gamma3 U-Blade Lag Screw Gamma3 U-Blade End Cap Fig. 1: Gamma3 U-Blade Lag Screw Set disassembled Fig. 1a: Gamma3 U-Blade Lag Screw Set assembled and spread Design Features of the Gamma3 Design Benefits of the Gamma3 . U-Blade Lag Screw Set U-Blade Lag Screw Set The Gamma3 U-Blade Lag Screw Set The Gamma3 U-Blade spreads at features a combination of a standard the tip of the Gamma3 U-Blade Lag Gamma Lag Screw and a spreading Screw thread (Fig.)

5 1a), a useful feature blade . for treating especially rotational and unstable fracture situations of The implant components of the the proximal femur. The Gamma3 . Gamma3 U-Blade Lag Screw Set are U-Blade Lag Screw Set is designed made of Titanium Alloy (Ti6Al4V) to provide a monoaxial rotational (Fig. 1 & 1a) with Anodized Type II stability of the femoral head and neck surface. They are designed for use with fragment. The spreading effect also the Gamma3 trochanteric (Fig. 2) and increases the surface by 15% in the Gamma3 Long Nails. cranial-caudal direction comparing with the standard Gamma3 Lag Screw , The unique Gamma3 U-Blade Lag which results in even higher resistance Screw Set concept and its straight to failure [4] in order to improve forward instrumentation enables quick cut-out resistance that can particularly and secure insertion.

6 The insertion occur in osteoporotic bone. In the procedure of the Gamma3 U-Blade literature, a cut-out rate of 2 8% is Lag Screw is similar to the standard reported with ordinary lag screws [1, Fig. 2: Gamma3 U-Blade Lag Screw Gamma3 Lag Screw . Insertion of the 2, 3]. Set with the Gamma3 trochanteric Gamma3 U-Blade into the Gamma3 nail 180. U-Blade Lag Screw will be performed Summarized the design offers the with easy to use instrumentation. following major benefits: Monoaxial rotational stability of the femoral head and neck fragment [4] (no second lag Screw [1] Failure of femoral head fixation : a cadaveric or pin is needed as with other analysis of lag Screw cut-out with the gamma locking nail and AO dynamic hip Screw . Haynes RC, Poll RG, implant designs) Miles AW, Weston RB, Injury.

7 1997 Jun Jul; 28 (5 6): Increased resistance to cut-out of 337 341. the femoral head due to the larger [2] Cutting-out of the lag Screw after internal fixation with the Asiatic Gamma nail . Kawaguchi S, Sawada implant surface [4] K, Nabeta Y. Injury. 1998 Jan; 29 (1): 47 53. Fully compatible with the Gamma3 [3] The Standard Gamma nail : A Critical Analysis of 1000 Cases. Kukla C, Heinz T, Gaebler C, Heinze G, nail System. Vecsei V., J Trauma 2001 Jul; 51 (1): 77 83. [4] Data on file 4. Indications and Contraindications Indications and Contraindications The Gamma3 U-Blade Lag Screw Set Note: is recommended for the following Follow the Gamma3 Operative indications: Technique for trochanteric or Highly osteoporotic bone in the Long Nails, depending which femoral head nail you are using, up to the Short femoral head/neck fragment part of the chapter entitled (Fig.)

8 2a) Lag Screw Insertion where the Unstable pertrochanteric or K-Wire is in place, the Lag Screw intertrochanteric fractures length determination has been with missing medial-caudal done and the value of the length bone support as shown in the measurement has been transfered preoperative X-Rays (Fig. 2b). to adjustable stop of the Lag Screw Step Drill. At this point, continue with this Operative Technique. Relative Contraindications The instructions for the Gamma3 . U-Blade Lag Screw Operative Fig. 2a: Preoperative X-Ray: Frac- The physician s education, training Technique should not interfere ture with short femoral head/neck and professional judgement must with or replace any chapters in the fragment be relied upon to choose the most Gamma3 Operative Technique appropriate device and treatment.

9 Except for those detailing Lag Conditions presenting an increased Screw insertion and fixation . This risk of failure include: manual is discribing the surgical Any active or suspected latent technique using a Gamma3 . infection or marked local trochanteric nail 180. inflammation in or about the affected area. For optimal positioning of the Compromised vascularity that Gamma3 U-Blade Lag Screw , use would inhibit adequate blood of the Gamma3 One Shot Device is supply to the fracture or the recommended. operative site. Bone stock compromised by The Gamma3 One Shot Device is a disease, infection or prior radiolucent instrument that is used implantation that can not provide to find the ideal position for the adequate support and/or fixation Lag Screw before skin incision and of the devices.

10 Opening the lateral cortex for K-Wire Material sensitivity, documented placement. or suspected. Fig. 2b: Preoperative X-Ray: Fracture Obesity. An overweight or obese with missing medial-caudal bone patient can produce loads on the support implant that can lead to failure of the fixation of the device or to failure of the device itself. Patients having inadequate tissue coverage over the operative site. Implant utilization that would interfere with anatomical structures or physiological performance. Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care. Other medical or surgical conditions which would preclude the potential benefit of surgery. Operative Technique Operative Technique (Ref No: B0300008) (Ref No: B0300009).