BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    MDR report key: 3250259 · Received July 24, 2013

    Report

    Report Number
    3006524618-2013-00303
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K081893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE USING SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE, THE IMPLANT BROKE OFF OF THE DEVICE UPON TENSIONING. THE SURGEON ABANDONED THE IMPLANT IN THE BONE AND DRILLED A NEW BONE HOLE, COMPLETING THE PROCEDURE WITH A NEW SPEEDSCREW IMPLANT. 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
    345881 SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD MBI ARTHROCARE CORPORATION 1025455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other