BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPEEDSCREW 5.5 MM KNOTLESS FIXATION DEVICE

    MDR report key: 2011689 · Received March 1, 2011

    Report

    Report Number
    2032380-2011-00020
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    January 24, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ARTHROCARE CORP
    Product Code
    HWC
    PMA / PMN Number
    K081893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FURTHER INFO. A SECOND DEVICE USED IN THE SAME PROCEDURE WAS FILED UNDER MDR 2032380-2011-00021. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO ARTHROCARE ON (B)(6) 2011 THAT A PT UNDERWENT AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2011 USING TWO OPUS SPEEDSCREW 5.5 IMPLANTS. REPORTEDLY, THE IMPLANTS CRACKED AND BROKE UPON PLACEMENT INTO BONE. THE SURGEON REVERTED FROM AN ARTHROSCOPIC METHOD TO A MINI-OPEN PROCEDURE TO COMPLETE THE SURGERY, AND ALL BROKEN PIECES WERE REMOVED FROM THE SURGICAL SITE. REPORTEDLY, THERE WAS NO ADVERSE EFFECT TO THE PT OR PT INJURY.

    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 CORP 1009943

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other