BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 861715 · Received May 31, 2007

    Report

    Report Number
    861715
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    May 25, 2007
    Report Date
    May 31, 2007
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE CANNULA WHEN HE DISCOVERED THE TIP OF THE CANNULA WAS BROKEN OFF. THE STAFF SEARCHED THE FIELD AND THE OPERATING ROOM. THE BROKEN PART OF THE CANNULA WAS DISCOVERED ON THE BACK TABLE COVER. NO PIECES WERE RETAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CANNULA NBH ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * 634812653

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR