RibFix Blu. Thoracic Fixation System
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- Norma Chandler
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1 RibFix Blu RibFix Blu Thoracic Fixation System
2 The New Era of Rib Fixation Begins Now Designed by Trauma Surgeons for Trauma Surgeons Your work matters and so do your patients. We are continually engineering new tools and techniques to help improve your efficiency in the operating room. The RibFix Blu Thoracic Fixation System is designed with this in mind. The system s innovative plate-to-bone approximation tools allow for the precise placement of plates along the rib, and unique plate-contouring instrumentation eliminates the need to remove the implant from the surgical field - saving you precious time when minutes matter. Indications RibFix Blu is indicated for use in the stabilization and rigid fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma or planned osteotomies. The system may be used in normal and poor bone to promote union.
3 RibFix Blu Thoracic Fixation System A Comprehensive, Customizable Rib Fixation System The RibFix Blu Thoracic Fixation System includes a selection of straight and pre-contoured plates and self-drilling as well as self-tapping screws, making the system easy to master in any surgical setting.
4 Unique Instruments Plate-to-Bone Approximation Tools Innovative temporary fixation screws and bayoneted plate-holding forceps reduce the plate flush to bone and aid with precise placement along the midline of the rib - freeing your hands to implant self-drilling screws. Temporary Fixation Screws Temporary Fixation Screw in Place Without Driver Bayoneted Plate-Holding Forceps
5 RibFix Blu - Features and Benefits Plate-Contouring Tools Engineered with the goal of expanding bend options, the RibFix Blu Thoracic Fixation System includes threaded and in-situ plate benders. The benders allow for adjustments to the plate in all planes - including torsional - eliminating the need to remove the implant from the surgical field. Threaded Plate Benders In-Situ Plate Benders In-Situ Plate Adjustments MIS Instrumentation The RibFix Blu Thoracic Fixation System offers minimally-invasive solutions for plating hard-to-reach rib fractures. Proximal posterior fractures that are generally inaccessible can be plated via trans-scapular or sub-scapular approaches using the MIS instrumentation. Both methods mobilize the scapula for easier maneuverability. Contra-Angle Screwdriver Trocar Assembly
6 Innovative Implant and Screw Design Implant Design Features Pre-contoured in two planes to fit the average anatomical rib shape Narrow plate design for easy alignment and minimal intra-operative contouring Universal plate selection - any plate can be applied to any rib on either the left or right side 1.6mm profile and deep counter-sunk screw holes provide minimal palpability Commercially-pure titanium for flexibility and strength 30cm In-plane bend radius Deep counter-sink of threaded screw hole 20cm Out-of-plane bend radius Single-sided design
7 RibFix Blu - Features and Benefits Self-Drilling Screw Self-drilling screws designed to be driven directly into the bone with no need for pre-drilling. Cancellous Screw Design Deeper screw threads provide optimal engagement into the cancellous bone of the chest wall. Innovative Locking Technology Screw threads lock into the plate while the tip engages the posterior cortex of the rib. These dual points of stability are crucial for the dynamic motions of the chest wall.
8 RibFix Blu - Bench Testing The RibFix Blu Thoracic Fixation System was tested in plastic blocks under dynamic motion testing using ASTM F1717 as a guide and subjected to bending loads of 400Nmm 1 for 1,000,000 cycles 2. This is equivalent to 10X the normal respiratory loading and more than six weeks of fracture healing. All constructs were able to withstand the exaggerated loading without any failures. Dynamic Motion Bending Test RibFix Blu plates and screws were fixated onto plastic blocks. Side supports were then connected to the plastic blocks with hinge pins. The inferior support was attached to the load cell base plate while the superior support was rigidly attached to the hydraulic actuator. The load cell base plate remained stationary while the hydraulic actuator pushed downward creating rotation in the vertical axis. ASTM F1717 was used as a guide because the dynamic compression motion of the test simulates the motion that a rigid implant for the ribs would experience. 1 Internal Testing Report, LT1474, Fatigue testing of RibFix Blu plate and screw constructs. 2 The estimate for the amount of cycles representative of fracture healing is based on 14.1 breaths per minute. 3 Internal Testing Report, LT1476, RibFix Blu plate and screw construct in cadaver bone testing 4 Internal Testing Report, LT1477, RibFix Blu plate and screw construct in cadaver bone testing Bench testing is not indicative of clinical performance.
9 RibFix Blu - Biomechanical Testing Test Summary The RibFix Blu Thoracic Fixation System was tested in human cadaveric osteopenic rib bones. Fractured ribs were stabilized with the RibFix Blu Fixation System and subjected to 5X the normal respiratory loads for 360,000 cycles, simulating a two-week fracture healing period. All constructs were able to withstand the exaggerated loading without any failures. Figure 1. The intact osteopenic rib was situated in the frame for biomechanical cadaveric testing. 3 Figure 2. Compressive loads were applied to create a realistic fracture pattern within the rib. 3 Figure 3. The rib was measured, and the fracture segments were reduced and plated using the appropriate size RibFix Blu plate and appropriate length screws, ensuring a minimum of three screws were implanted on both sides of the fracture. 3 Fig. 2 Figure 4. Biomechanical testing was repeated on the fixated rib in a humid environment resembling physiologic conditions. 4 Fig. 3 Fig.1 Fig. 4
10 RibFix Blu - Instruments Bayoneted Plate-holding Forceps, Left Bayoneted Plate-holding Forceps, Right Rib Elevator Screw Sizer Trocar Handle Soft-tissue Retractor Non-threaded Drill Guide Trocar Cannula Scapula Drill Guide Items not to scale
11 RibFix Blu - Instruments Trocar, Long Threaded Plate Bender, Cannulated In-Situ Plate Bender Contra-angle Screwdriver Torque Handle Contra-angle Screwdriver mm Plate-holding Wand Depth Gauge, 45mm Long Plate-holding Forceps Fiber Optic Cable Items not to scale
12 RibFix Blu - Instruments Plate Cutter Large Plate Bender Bone-reduction Forceps Drills, Blades, Drivers Power Driver Blade Screwdriver Blade Screwdriver Blade, Long Contra-angle Screwdriver Blade SP mm Adjustable Drill Bit, Short mm Adjustable Drill Bit, Long Temporary Fixation Screw Items not to scale
13 RibFix Blu - Drills, Blades, Drivers Power Driver Scapula Drill Black Ratcheting Handle Power Driver Battery mm/2.7mm Screws Self-Drilling Locking Screws (Green) Self-Tapping Screws (Silver) Rescue Screws (Purple) Part No. Description Part No. Description Part No. Description x 7mm x 7mm x 7mm x 8mm x 8mm x 8mm x 10mm x 10mm x 10mm x 12mm x 12mm x 12mm x 14mm x 14mm x 14mm x 16mm x 16mm x 16mm Items not to scale
14 RibFix Blu - Implants Plates Templates 8- Hole Straight Plate Hole Plate Template Hole Pre-Contoured Plate Hole Plate Template Hole Pre-Contoured Plate Hole Plate Template Hole Pre-Contoured Plate Hole Plate Template Items not to scale
15 Self-Drilling 76-24XX Self-Drilling 76-24XX Self-Drilling 76-24XX Self-Drilling Self-Drilling 76-24XX 76-24XX 76-24XX Self-Tapping 76-25XX Self-Tapping 76-25XX Self-Tapping 76-25XX Self-Tapping Self-Tapping 76-25XX 76-25XX 76-25XX Emergency 76-27XX Emergency 76-27XX Emergency Emergency 76-27XX 76-27XX SP-2379 SP-2379 SP-2379 SP RibFix Blu - Tray Components Containers and Tray Components Outer Container Base Screw Caddy* Implant Caddy* Instrument Tray Insert Mat, Short Mat, Long Complete Tray Container Lid Power Driver Tray (tray only) Tray ID Set *Caddies only. No Implants or screws included Items not to scale
16 RibFix Blu For more information on RibFix Blu and other thoracic fixation solutions, please contact us at: BIOMET MICROFIXATION GLOBAL HEADQUARTERS 1520 Tradeport Drive Jacksonville, FL Tel Toll-Free Fax Order Fax EUROPE Toermalijnring LC Dordrecht The Netherlands Tel Fax All content herein is protected by copyright, trademarks and other intellectual property rights owned by or licensed to Zimmer Biomet Inc. or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet. This material is intended for healthcare professionals and the Zimmer Biomet sales force. Distribution to any other recipient is prohibited. Zimmer Biomet does not practice medicine. The treating surgeon is responsible for determining the appropriate treatment, technique(s), and products for each individual patient. For complete product information, including indications, contraindications, warnings, precautions, and potential adverse effects, see the package insert or visit our website at Zimmer Biomet Form No. BMF Rev 03k1508
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