BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFIRE SCORPION

    MDR report key: 1217143 · Received October 23, 2008

    Report

    Report Number
    1217143
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ARTHREX SUREFIRE SCORPION NEEDLE BROKE AT NOTCH APPROX. 3MM FROM TIP.====================== MANUFACTURER RESPONSE FOR NEEDLE, ROTATOR CUFF REPAIR DEVICE, SUREFIRE SCORPION NEEDLE======================OR MATERIALS MANAGER HAS NOTIFIED THE REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIRE SCORPION NEEDLE, SUTURE MDM ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * 170418

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR