BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    MDR report key: 3193159 · Received June 25, 2013

    Report

    Report Number
    3006524618-2013-00245
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HWC
    PMA / PMN Number
    K081893
    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 SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE, THE IMPLANT WOULD NOT LOCK OR RELEASE FROM HANDLE. A SECOND IMPLANT WAS OPENED AND THIS UNIT ALSO FAILED TO LOCK OR RELEASE. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITOR'S DEVICE. 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
    288182 SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE FIXATION ANCHOR, LIGAMENT, NON-BIODEGRADABLE HWC ARTHROCARE CORPORATION 1033788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OM-6500 SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDL| LOT NUMBER: 1033788