BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDLOCK IMPLANT WITH INSERTER HANDLE

    MDR report key: 3240991 · Received July 17, 2013

    Report

    Report Number
    3006524618-2013-00289
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K090615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BANKART REPAIR PROCEDURE USING A SPEEDLOCK IMPLANT WITH INSERTER HANDLE, UPON DEPLOYMENT THE IMPLANT PULLED OUT OF THE BONE. A SECOND IMPLANT WAS OPENED AND UPON DEPLOYMENT, THE DISTAL TIP OF THE IMPLANT BROKE. IT WAS NECESSARY TO DRILL A NEW BONE HOLE AND A THIRD IMPLANT WAS SUCCESSFULLY IMPLANTED. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332022 SPEEDLOCK IMPLANT WITH INSERTER HANDLE FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD MBI ARTHROCARE CORPORATION 1019338

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other