BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSCREW KNOTLESS IMPLANT W/INSERTER HANDLE

    MDR report key: 2850168 · Received November 21, 2012

    Report

    Report Number
    3006524618-2012-00914
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K081893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN AUTO CUFF PROCEDURE USING AN OPUS SPEEDSCREW KNOTLESS IMPLANT, THE SUTURING WAS UNSUCCESSFUL DUE TO LACK OF TENSION. THE ANCHOR WAS REMOVED AND A BACK-UP OPUS SPEEDSCREW KNOTLESS IMPLANT WAS USED IN THE EXISTING BONE HOLE. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY. NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDSCREW KNOTLESS IMPLANT W/INSERTER HANDLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION 1026038

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other