BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLIPCUTTER II

    MDR report key: 3033423 · Received March 12, 2013

    Report

    Report Number
    3033423
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    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

    ARTHREX FLIPCUTTER (11MM) BROKE IN HALF WHILE BEING USED ON A PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RIGHT KNEE SURGERY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104364 FLIPCUTTER II ARTHROSCOPE HRX ARTHREX, INC. * 302439227

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR