BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDLOCK IMPLANT WITH INSERTER HANDLE

    MDR report key: 3202027 · Received June 27, 2013

    Report

    Report Number
    3006524618-2013-00247
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K090615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LABRAL REPAIR USING THE SPEEDLOCK IMPLANT WITH INSERTER HANDLE, A PIECE OF THE METAL SHAFT SNAPPED OFF UPON INSERTION, WHILE INSIDE THE SURGICAL SITE. THE PIECE WAS IMMEDIATELY RETRIEVED; HOWEVER, THE IMPLANT WAS UNUSABLE AND WAS ABANDONED IN THE BONE. A NEW BONE HOLE WAS DRILLED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP IMPLANT. 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
    293175 SPEEDLOCK IMPLANT WITH INSERTER HANDLE FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD MBI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other