BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTROL BAR ASSEMBLY

    MDR report key: 3101438 · Received May 3, 2013

    Report

    Report Number
    1526350-2013-00225
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROL BAR ASSEMBLY WAS RECEIVED WITH BURRS. IT WAS ALSO REPORTED THAT THE PARTS WERE RECEIVED WITHOUT PROTECTIVE WRAPPING, CAUSING THE BURRS. THE DEVICE WAS NOT IN PT USE AND THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194722 CONTROL BAR ASSEMBLY CONTROL BAR ASSEMBLY GFD ZIMMER SURGICAL NA 61896780

    Patients

    Seq Age Sex Outcome Treatment
    1