BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFIRE SCORPION

    MDR report key: 1243796 · Received November 19, 2008

    Report

    Report Number
    1243796
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 19, 2008
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A ROTATOR CUFF REPAIR SURGERY, THE TIP OF THE SCORPION NEEDLE BROKE OFF INTO THE ROTATOR CUFF OF THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIRE SCORPION NEEDLE, SUTURE GAB ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * 183356

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR