BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFLEX KNOTLESS FIXATION DEVICE

    MDR report key: 2852939 · Received November 27, 2012

    Report

    Report Number
    3006524618-2012-00926
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K120096
    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 THE MULTIFIX KNOTLESS FIXATION DEVICE, THE DEVICE TIP BROKE OFF INSIDE THE PATIENT WHILE THE SURGEON WAS MALLETING THE ANCHOR. THE BROKEN TIP WAS RETRIEVED FROM THE PATIENT ARTHROSCOPICALLY AND THE SUTURES WERE ABLE TO BE REUSED. THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING A NEW ANCHOR IN THE SAME BONE HOLE. NO SIGNIFICANT DELAYS OR FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFLEX KNOTLESS FIXATION DEVICE FIXATION ANCHOR, LIGAMETN, NON-BIODEGRAD MBI ARTHROCARE CORPORATION W120049

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other