BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    MDR report key: 1914487 · Received November 23, 2010

    Report

    Report Number
    2032380-2010-00027
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    MBI
    PMA / PMN Number
    K081893
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT INFO WAS REQUESTED BUT WAS NOT AVAILABLE. A LOT HISTORY REVIEW WAS PERFORMED FOR THE DEVICE LOT. NO ABNORMALITIES WERE IDENTIFIED THAT WOULD LEAD TO THE REPORTED PRODUCT PROBLEM. THE DEVICE WAS RECEIVED UNDEPLOYED. THE IMPLANT WAS FOUND INTACT. THE SNARE LINES WERE FOUND WRAPPED AROUND THE REELS WITHOUT CLINICAL SUTURE. THE GREEN SNARE LINE WAS FOUND INTACT AND THE WHITE SNARE LINE WAS FOUND WITH ITS LOOP BROKEN OFF. THE SNARE LOOP WAS FOUND ON THE DISTAL END OF THE SHAFT. IT IS POSSIBLE THAT THE LOOP BROKE DUE TO EXCESSIVE TENSION APPLIED DURING THE CINCHING PROCESS; HOWEVER, AN EXACT ROOT CAUSE IS NOT KNOWN. A SECOND DEVICE USED IN THE SAME PROCEDURE WAS FILED UNDER MDR 2032380-2010-00026. (B)(4).

    Description of Event or Problem · 1

    THE PT UNDERWENT A ROTATOR CUFF REPAIR AND SUBACROMIAL DECOMPRESSION SURGERY USING TWO OPUS SPEEDSCREW 5.5 IMPLANTS. FOR THE FIRST IMPLANT USED, THE DEVICE FAILED TO TENSION DURING THE LOADING OF THE SUTURE INTO THE IMPLANT AND THE IMPLANT WAS REMOVED AND SECOND IMPLANT PLACED IN THE SAME BONE HOLE. DURING THE TENSION OF THE SECOND IMPLANT, THE CROSS PIN BROKE AND THE SURGEON COULD NOT USE THE DEVICE AS PROPER TENSIONING WAS NOT ACHIEVED. THE SURGEON ELECTED TO MOVE TO A MINI-OPEN PROCEDURE TO COMPLETE THE REPAIR USING A BONE TUNNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE FASTENER, FIXATION, NONDEGRADABLE, SOFT MBI ARTHROCARE CORP. 1011605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other