The Flower Proximal Humerus Plate

Transcription

1 The Flower Proximal Humerus Plate PROCEDURE GUIDE

2 The Flower Upper Extremity Application PROXIMAL HUMERUS PLATE SMALL BONE PLATES FOUR CORNER FUSION PLATE ANATOMIC DISTAL RADIUS PLATE INDICATIONS FOR USE: The Flower Small and Medium Implants set is intended for use for internal fixation of fractures and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot in adults and for use in long bones in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, ventral, dorsal and orthogonal application. 2 The Flower Proximal Humerus Plate Procedure Guide

3 The Flower Proximal Humerus Plate Product Rationale The Flower Proximal Humerus Plate Construct consists of a high-strength stabilization plate designed to best accommodate biomechanical considerations of the proximal humerus. The anatomic curvature of the Flower Proximal Humerus plate is designed for efficient placement and can be bilaterally applied to right and left. The Flower Proximal Humerus Plate accepts both variable angle locking and non-locking screws. The Flower Proximal Humerus Plate Design Features PLATE RATIONALE Anatomically contoured SURGICAL BENEFIT Facilitates anatomic reduction and limits need for bending Contains suture holes on the perimeter of the proximal end Aids in reduction and tuberosity fixation Plates accept 3.5mm and 4.0mm variable angle locking and non-locking screws Provides multiple screw options for optimal system stability Screws sit flush, or below the top surface of the plate Reduced risk of soft tissue irritation The Flower Proximal Humerus Plate Procedure Guide 3

4 The Flower Proximal Humerus Plate Surgical Strategy Step 1 Fracture Reduction and Provisional Fixation Using K-Wires a. With the fracture properly reduced, the Flower Large Bone K-Wires (FIM 115) are directed through the fracture line to provide provisional stability. b. A minimum of two k-wires are required to stabilize the fracture before applying the plate. c. Place k-wires to avoid interference with plate placement Step 2 Plate Placement Using Flower K-Wires (KWK 002) a. A plate trial (FIM 460) is available to determine the appropriate plate length before opening the sterile packaged plate. The plate trial may also be used as a bending template if required. b. Center the Flower Proximal Humerus Plate on the lateral aspect of the proximal humerus and on the greater tuberosity. c. The plate can be temporarily fixed to the bone using Flower K-Wires, placed through the k-wire holes in the plate. Step 3 Drill Holes and Screw Placement a. 3.5mm variable angle locking or non-locking screws are recommended for the Flower Proximal Humerus Plate Construct, depending on the surgeon s preference. b. Starting with the proximal locking holes and using a 2.5mm drill bit (DBK 035), drill pilot holes. Use the locking end of the drill guide for all holes in the plate. 4 The Flower Proximal Humerus Plate Procedure Guide

5 The Flower Proximal Humerus Plate Surgical Strategy Step 4 Placement of Locking Screws a. Insert the depth gauge (included in KWK 002) into the drill hole. b. It is important that the instrument is fully seated into the screw hole before the hook probe is advanced into the pilot hole. c. The hook of the depth gauge is engaged behind the opposite cortex of the pilot hole and the pilot hole depth can be read off the distal end of the slider. Note: It is recommended that 2-4mm be subtracted from the measured length in order to avoid screw penetration into the glenohumeral joint. Intraoperative fluoroscpy is also helpful to assure proper screw length d. Insert the locking screws into the proximal screw holes using the Flower Torque Limiting Screwdriver that is part of the Flower K-Wire Kit (KWK 002). Note: Screws may be inserted 90% of their length using the Flower Speed Driver Bit (FIM 115). The final two turns to produce locking of the screw into the plate MUST be achieved with the Flower Torque Limiting Screwdriver to prevent over-tightening. e. If inserting non-locking screws, the screws should be inserted until flush with the top of the plate, and the torque limiting feature should not be engaged. Step 5 Placement of Non-Locking Screws a Insert 4.0mm variable angle non-locking screws into the Flower locking holes. b. Using a 3.0mm drill bit (DBK 040), drill pilot holes. Use the locking end of the drill guide for all holes in the plate. c. Repeat step 4 for length measurement and screw insertion. Step 6 Final Construct The Flower Proximal Humerus plate addresses the various and often difficult fracture patterns of the shoulder. The bilateral designs provides consistent anatomic reduction and targeted fixation, with limited need for bending. The Flower Proximal Humerus Plate Procedure Guide 5

6 The Flower Proximal Humerus Plate Implant Selection VARIABLE ANGLE LOCKING SCREWS Screw Diameters Product Description Lengths 3.5mm 3.5mm Variable Angle Locking Screw 10mm-60mm 4 VARIABLE ANGLE NON-LOCKING SCREWS Screw Diameters Product Description Lengths 3.5mm 3.5mm Variable Angle Non-Locking Screw 10mm-60mm 4.0mm 4.0mm Variable Angle Non-Locking Screw 10mm-60mm 4 FLOWER PROXIMAL HUMERUS PLATE PORTFOLIO Product Description Length FRP mm Proximal Humerus Plate, 9 holes 90.5mm FRP mm Proximal Humerus Plate, 10 holes 103.5mm FRP mm Proximal Humerus Plate, 11 holes 116.5mm FRP mm Proximal Humerus Plate, 12 holes 129.5mm FRP mm Proximal Humerus Plate, 13 holes 142.5mm 6 The Flower Proximal Humerus Plate Procedure Guide

7 The Flower Proximal Humerus Plate Single-Use Instrument Overview PROXIMAL HUMERUS PLATE TRIALS FIM 460 Proximal Humerus Trials K-WIRE KIT (KWK 002) Kit Size K-Wire Kit, Torque Wrench (Small), Depth Gauge (Medium) Medium K-Wire, D: 1.0mm (2 pieces) LARGE BONE K-WIRE KIT FIM 115 Power Screw Driver Bit, D:1.4mm K-Wires (2) LAG SCREW KITS LSK 035 LSK 040 Drill Bit 3.5mm, Lag Screw Drill Guide Drill Bit 4.0mm, Lag Screw Drill Guide DRILL BIT KITS DBK 035 DBK 040 Drill Bit D:2.5mm, Drill Guide Drill Bit D:3.0mm, Drill Guide PLATE BENDERS FIS 234 Plate Benders (M) (2 Pieces) The Flower Proximal Humerus Plate Procedure Guide 7

8 FlowerCube : Schedule. Treat. Turn. Schedule Case Sooner. (Ready-for-Surgery ) Treat Confidently. (Sterile & Disposable) Turn OR Faster. (FlowerCube) No cleaning and sterilization FlowerCube is always ready to complete the case No time consuming set drop off Instrument kits are always complete Drill bits are always sharp Guaranteed sterility FlowerCube is always ready for the next surgery No delay with back to back cases Enough sterile inventory for multiple cases Flower Orthopedics Corporation 100 Witmer Road Suite 280 Horsham, PA T: F: FOCPG-UE-003 RevA 5/15