BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI PROXIMAL TIBIA LISS PLATE 5 HOLES/140MM-LEFT

    MDR report key: 2924508 · Received January 22, 2013

    Report

    Report Number
    8030965-2013-00193
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K961413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED. EXCEPT FOR THE 4 DAMAGED THREADED LOCKING SCREW BORES, THE PLATE IS NOT DAMAGED BUT SHOWS MARKS AND WEAR. THREE LOCKING HEAD SCREWS STILL ARE BLOCKED IN THE PLATE NEVERTHELESS THEIR HEADS ARE DRILLED OUT AND DAMAGED COMPLETELY. A FOURTH THREADED LOCKING HOLE WAS DAMAGED DURING DRILLING OUT THE HEAD OF A LOCKING HEAD SCREW. FIVE THREADED LOCKING SCREW BORES VISIBLY ARE NOT DAMAGED. DUE TO THE DAMAGE, THE DIMENSIONS ON THE CONCERNED THREADED LOCKING SCREW BORES CANNOT BE CHECKED ANYMORE. A FUNCTIONAL TEST WAS PERFORMED SUCCESSFULLY ON THE UNDAMAGED THREADED LOCKING SCREW BORES WITH AN INTACT LOCKING HEAD SCREW. THE DHR REVIEW SHOWS THAT THE DEVICE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS AND THAT THE CORRECT MATERIAL WAS USED. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    (B)(4): COLD WELDED, GALLED, STUCK SCREWS CAN BE AN ISSUE WITH TITANIUM PLATES AND SCREWS. THIS ISSUE HAS BEEN STUDIED NUMEROUS TIMES INTERNALLY AND WITHIN THE PEER REVIEWED LITERATURE WITH MIXED BELIEFS AS TO THE CAUSE. ONE IS THAT DURING SCREW INSERTION, THE SCREWS ARE OVER TORQUED CAUSING A GALLING SITUATION AND THE OTHER IS THAT BIO INTEGRATION, BONE IN-GROWTH, PROTEIN BRIDGING, CAN CAUSE THE SCREWS TO STICK. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH LEFT PROXIMAL TIBIA LISS PLATE FIXATION ON (B)(6) 2012 RETURNED TO THE SURGEON COMPLAINING ABOUT THE PLATE PROTRUDING THROUGH THE SKIN. REPORTEDLY AN EXAM ON UNKNOWN DATE INDICATED FRACTURE WAS HEALED. SURGEON RETURNED THE PATIENT TO THE O.R. ON (B)(6) 2012 FOR REMOVAL OF THE LISS PLATE AND SCREWS. DURING THE REMOVAL, IT WAS FOUND THAT FOUR OF THE SCREWS HAD BECOME COLD-WELDED TO THE PLATE. THE SURGEON BROKE THREE SCREWDRIVERS, TWO CONICAL EXTRACTION SCREWS AND ONE T-HANDLE IN TRYING TO REMOVE THE COLD-WELDED SCREWS. SURGEON HAD TO DRILL OUT THE FOUR SCREWS TO REMOVE THE PLATE. ALL SCREW SHAFT FRAGMENTS WERE CONFIRMED AS RETRIEVED. OTHER SCREWS IN THE PLATE WERE REMOVED WITHOUT DIFFICULTY. THE SURGEON COMPLETED THE PROCEDURE, AND THE PATIENT IS REPORTEDLY RECOVERING WELL. THIS IS 1 OF 10 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30464 TI PROXIMAL TIBIA LISS PLATE 5 HOLES/140MM-LEFT TI PROXIMAL TIBIA LISS PLATE HWC SYNTHES GMBH 2666880

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention SCREWS