BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM2 KNOTLESS IMPLANT

    MDR report key: 3902525 · Received May 7, 2014

    Report

    Report Number
    3006524618-2014-00143
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K042914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING A MAGNUM2 KNOTLESS IMPLANT WITH A SMARTSTITCH PERFECTPASSER SUTURE CARTRIDGE, IT WAS DISCOVERED THAT THE SUTURES HAD BECOME LOOSE AFTER THE IMPLANT WAS DEPLOYED. THE SURGEON OPTED TO CUT THE SUTURES ON THIS IMPLANT AND DOUBLE STACK A NEW LIKE IMPLANT ON TOP OF THE INITIAL MAGNUM2 IMPLANT, 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
    276811 MAGNUM2 KNOTLESS IMPLANT FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD MBI ARTHROCARE CORPORATION 1046129

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other OM-8176EA, LOT #1047099| SMARTSTITCH PERFECTPASSER SUTURE CARTRIDGE: