BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX

    MDR report key: 1772183 · Received July 21, 2010

    Report

    Report Number
    MW5016822
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 21, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING RIGHT SHOULDER ARTHROSCOPY WITH ROTATOR CUFF REPAIR. SCORPION SUREFIRE NEEDLE WAS BEING USED. THE TIP OF THE NEEDLE BROKE OFF. THE TIP WAS NOT IN THE PT'S JOINT/JOINT SPACE. TIP WAS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX SUREFIRE SCORPION NEEDLE HRX ARTHREX, INC. AR-13991N 194333

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR