BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM2 KNOTLESS IMPLANT

    MDR report key: 3994354 · Received July 23, 2014

    Report

    Report Number
    3006524618-2014-00217
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    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 SHOULDER PROCEDURE USING A MAGNUM 2 KNOTLESS IMPLANT, THE IMPLANT WAS NOT OPENING PROPERLY PREVENTING THE DEVICE FROM STAYING IN THE BONE. THIS HAPPENED WITH TWO ADDITIONAL LIKE IMPLANTS. AFTER A 30 MINUTE SURGICAL DELAY CAUSED BY THESE DEFICIENCIES, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH PROPERLY FUNCTIONING MAGNUM 2 KNOTLESS IMPLANTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432382 MAGNUM2 KNOTLESS IMPLANT FIXATION ANCHOR, LIGAMENT, NON-BIODRADEABLE MBI ARTHROCARE CORPORATION 1068612

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #: 1068612| MAGNUM2 KNOTLESS IMPLANT: CAT #: OM-1502 (2),