BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDLOCK IMPLANT WITH INSERTER HANDLE

    MDR report key: 3193158 · Received June 25, 2013

    Report

    Report Number
    3006524618-2013-00244
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K090615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LABRUM FIXATION PROCEDURE USING THE SPEEDLOCK IMPLANT WITH INSERTER HANDLE, THE SUTURE THREAD BROKE UPON TENSIONING. THE IMPLANT WAS ABANDONED IN THE BONE AND A NEW BONE HOLE WAS DRILLED TO COMPLETE THE PROCEDURE. 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
    287075 SPEEDLOCK IMPLANT WITH INSERTER HANDLE FIXATION ANCHOR, LIGAMENT, NON-BIODEGRADABLE MBI ARTHROCARE CORPORATION 1025004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other