BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE CANNULA

    MDR report key: 1333455 · Received February 26, 2009

    Report

    Report Number
    1333455
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    February 13, 2009
    Report Date
    February 26, 2009
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    AN ARTHREX PLASTIC 5MM LOW PROFILE CANNULA BROKE DURING A LEFT ARTHROSCOPIC LABRAL REPAIR. ALL OF THE BROKEN PIECES WERE RETRIEVED AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE CANNULA CANNULA, ARTHROSCOPIC HRX ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * 835119734

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR