BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI SR8

    MDR report key: 3943327 · Received July 11, 2014

    Report

    Report Number
    3943327
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING AN ARTHREX GEMINI CANNULA DURING SHOULDER ARTHROSCOPY. THE CANNULA HAS 2 WINGS THAT FLARE OUT ON THE END OF THE CANNULA. ONE OF THE WINGS BROKE OFF WHILE INSIDE THE PATIENT'S SHOULDER. SURGEON WAS ABLE TO FISH THE BROKEN PIECE OUT OF THE PT'S SHOULDER. CANNULA INSPECTED AND WAS INTACT. CANNULA SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407479 GEMINI SR8 ARTHROSCOPE HRX ARTHREX, INC. * 021401

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR