BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTETRAK

    MDR report key: 3071081 · Received April 8, 2013

    Report

    Report Number
    1038671-2013-00025
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 16, 2013
    Report Date
    April 8, 2013
    Manufacturer
    EXACTECH, INC.
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION IS PENDING.

    Description of Event or Problem · 1

    WHILE IMPACTING THE FINISHING GUIDE ON THE DISTAL FEMUR, ONE OF PEGS BROKE AND FELL OFF. THIS RESULTED IN THE SURGEON NEEDING TO MAKE A HIGHER BONE CUT THAN ORIGINALLY INTENDED TO DOWNSIZE FEMORAL COMPONENT. THIS EVENT OCCURRED OUTSIDE OF THE US IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144569 OPTETRAK FEMORAL FINISHING GUIDE FZX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other