BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    MDR report key: 2921910 · Received January 15, 2013

    Report

    Report Number
    3006524618-2013-00036
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HWC
    PMA / PMN Number
    K081893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACHILLES TENDON REPAIR USING THE OPUS SPEEDSCREW IMPLANT, THE IMPLANT BROKE OFF AS IT WAS BEING THREADED INTO THE BONE. THE IMPLANT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22963 SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE FIXATION ANCHOR, LIGAMENT, NON-BIODEGRADABLE HWC ARTHROCARE CORPORATION 1028336

    Patients

    Seq Age Sex Outcome Treatment
    1 Other