BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFEX DIRECTOR ELITE

    MDR report key: 1831801 · Received August 26, 2010

    Report

    Report Number
    1831801
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 26, 2010
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION. WHILE USING THE FEMORAL OFFSET CANNULA IT BROKE OFF IN THE PT, HOWEVER THE SURGEON WAS ABLE TO RETREIVE THE BROKEN PART. THE INSTRUMENT WAS PART OF THE VENDOR'S TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFEX DIRECTOR ELITE FEMORAL OFFSET CANNULA HRX SMITH AND NEPHEW * 50270509

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR