BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPEEDSCREW 5.5 MM KNOTLESS FIXATION DEVICE

    MDR report key: 2020223 · Received March 9, 2011

    Report

    Report Number
    2032380-2011-00017
    Event Type
    Other
    Date Received
    March 9, 2011
    Date of Event
    January 17, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HWC
    PMA / PMN Number
    K081893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WILL BE RETURNED FOR INVESTIGATION. TO DATE THE DEVICE HAS NOT BEEN REC'D. A F/U REPORT WILL BE SUBMITTED ONCE THE LOT HISTORY IS REVIEWED AND THE INVESTIGATION IS COMPLETE. A SECOND DEVICE USED IN THE SAME PROCEDURE WAS FILED UNDER MDR 2032380-2011-00016. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2011, THAT A PT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2011, USING TWO SPEEDSCREW 5.5 IMPLANTS. REPORTEDLY ONE SUTURE WAS NOT CORRECTLY THREADED INTO THE FIRST IMPLANT AND THE IMPLANT WAS LEFT IN THE PT'S SHOULDER W/O FUNCTION. THE SECOND IMPLANT WAS PROBLEMATIC AND WAS REMOVED FROM THE PT'S SHOULDER WITH FORCEPS. ADDITIONALLY IT WAS REPORTED ON (B)(6) 2011, THAT THE SURGEON WAS ABLE TO COMPLETE THE REPAIR WITH A THIRD IMPLANT, NO ADD'L INCISIONS, NO PT INJURY, AND A SURGICAL DELAY OF APPROX 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDSCREW 5.5 MM KNOTLESS FIXATION DEVICE FASTENER, FIXATION, NONDEGRADABLE, SOFT HWC ARTHROCARE CORPORATION 1012187

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other