BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    MDR report key: 3871200 · Received April 16, 2014

    Report

    Report Number
    3006524618-2014-00114
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    February 23, 2014
    Report Date
    March 18, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HWC
    PMA / PMN Number
    K081893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR USING A SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE, THE LOCKING MECHANISM ON THE IMPLANT REMAIN ATTACHED TO THE INSERTER TIP UPON RETRACTION. THIS HAPPENED AGAIN WITH AN ADD'L SPEEDSCREW IMPLANT, RESULTING IN A 30 MIN SURGICAL DELAY. THERE WERE NO REPORTED PT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233469 SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD HWC ARTHROCARE CORPORATION 1042984

    Patients

    Seq Age Sex Outcome Treatment
    1