BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QWIX FIXATION SCREW - EMM DIAMETER X 22MM LENGTH

    MDR report key: 1928986 · Received November 16, 2010

    Report

    Report Number
    9615741-2010-00058
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 16, 2010
    Manufacturer
    INTEGRA LIFESCIENCES SERVICES SAS
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE RPTR STATED THAT DURING AN AUSTIN BUNIONECTOMY SURGICAL PROCEDURE USING THE QWIX LOWER EXTREMITY FIXATION SCREWS, THE SCREW TIP CRUMBLED DURING INSERTION. THIS OCCURRED WITH TWO SCREWS. THERE WAS NO TORQUE BEING APPLIED AT THE TIME THIS HAPPENED. THE SCREW FRAGMENTS WERE REMOVED AND NO PIECES WERE SEEN ON FLUOROSCOPY. A DIFFERENT TYPE OF SCREW WAS USED FOR THE FIXATION. THE PT IS DOING WELL POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QWIX FIXATION SCREW - EMM DIAMETER X 22MM LENGTH NA HWC INTEGRA LIFESCIENCES SERVICES SAS

    Patients

    Seq Age Sex Outcome Treatment
    1