BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM

    MDR report key: 4142499 · Received October 6, 2014

    Report

    Report Number
    0009610622-2014-00536
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT HAD A SHORT GAMMA NAIL, LISS PLATE AND KNEE REPLACEMENT IN SITU. THERE WAS A GAP BETWEEN THE END OF THE NAIL AND WHERE THE LISS PLATE STARTED. THE PATIENT HAD FALLEN AND FRACTURED BETWEEN THIS GAP. SURGEON REMOVED THE SHORT GAMMA NAIL, TO EXCHANGE IT FOR A LONG ONE. HE TRIED TO PUT DISTAL LOCKING SCREWS FOR NAIL THROUGH THE SCREW HOLES IN THE PLATE; THEN THROUGH THE NAIL. HE WAS ADVISED THAT THIS WAS OFF-LABEL, HE WAS AWARE OF THE DANGERS BUT STILL DECIDED TO PROCEED. THE SCREWS THAT HE ATTEMPTED TO PUT THOUGH THE PLATE WERE STRIPPED OF THEIR THREAD (PLATE WAS STAINLESS STEEL, SCREW TITANIUM). SURGEON ATTEMPTED TO DO THIS WITH 3 SCREWS; THREADS STRIPPED OFF EACH OF THEM. HE THEN DECIDED TO REMOVE THE PLATE AND LOCK THE NAIL AS PER THE SURGICAL TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624688 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K581284

    Patients

    Seq Age Sex Outcome Treatment
    1 Other