BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM2 KNOTLESS IMPLANT

    MDR report key: 3123761 · Received May 14, 2013

    Report

    Report Number
    3006524618-2013-00184
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 18, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HTY
    PMA / PMN Number
    K042914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AUTO CUFF REFIXATION PROCEDURE USING THE MAGNUM2 KNOTLESS IMPLANT, AFTER INSERTION OF THE IMPLANT, THE ANCHOR WAS PULLED OUT OF THE BONE HOLE WHEN THE INSERTER WAS RETRACTED. AFTER A NEW BONE HOLE WAS DRILLED, A SECOND ANCHOR WAS IMPLANTED; HOWEVER, THIS ANCHOR WOULD NOT FULLY SCREW INTO THE BONE AND WAS REMOVED. A THIRD AND FOURTH ANCHOR WERE INSERTED; HOWEVER THE SURGEON WAS UNABLE TO GET THE ANCHORS TO FULLY LOCK INTO PLACE. THE LAST TWO ANCHORS WERE ABANDONED INSIDE THE PT. THE PROCEDURE WAS CONVERTED TO A MINI-OPEN AND THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITOR'S PRODUCT. THERE WAS A 30 MINUTE SURGICAL DELAY, BUT NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212916 MAGNUM2 KNOTLESS IMPLANT ORTHOPEDIC INTERNAL FIXATION SYSTEMS HTY ARTHROCARE CORPORATION 2333683

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other