BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE CANNULA

    MDR report key: 1392521 · Received April 17, 2009

    Report

    Report Number
    1392521
    Event Type
    Malfunction
    Date Received
    April 17, 2009
    Date of Event
    April 9, 2009
    Report Date
    April 17, 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

    ARTHREX CANNULA BROKE OFF IN THE PATIENT'S SHOULDER DURING ARTHROSCOPIC SURGERY. A SMALL INCISION WAS MADE TO RETRIEVE THE BROKEN PIECE OF THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE CANNULA CANNULA, ARTHROSCOPIC HRX ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * 904320318

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR