BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM2 KNOTLESS IMPLANT

    MDR report key: 2980327 · Received February 22, 2013

    Report

    Report Number
    3006524618-2013-00081
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HTY
    PMA / PMN Number
    K042914
    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 ROTATOR CUFF REPAIR PROCEDURE USING AS MAGNUM2 KNOTLESS IMPLANT, THE SUTURE BROKE DURING THE FINAL TENSIONING. THE IMPLANT WAS ABANDONED IN THE BONE AND IT WAS NECESSARY TO DRILL A NEW BONE HOLE. THE PROCEDURE WAS COMPLETED USING A NEW SUTURE AND NEW IMPLANT WITHOUT SIGNIFICANT DELAY. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77252 MAGNUM2 KNOTLESS IMPLANT FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD HTY ARTHROCARE CORPORATION 2286567

    Patients

    Seq Age Sex Outcome Treatment
    1 Other