BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    MDR report key: 3193173 · Received June 25, 2013

    Report

    Report Number
    3006524618-2013-00243
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HWC
    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 REFIXATION PROCEDURE USING THE SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE, THE SUTURE THREADS WERE NOT FEEDING PROPERLY INTO THE IMPLANT. THE IMPLANT WAS ABANDONED IN THE BONE AND A NEW BONE HOLE WAS DRILLED 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
    288802 SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE FIXATION ANCHOR, LIGAMENT, NON-BIOGRADABLE HWC ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other