BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTROL BAR ASSEMBLY

    MDR report key: 3099488 · Received May 2, 2013

    Report

    Report Number
    1526350-2013-00220
    Event Type
    Malfunction
    Date Received
    May 2, 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 CONTROL BAR ASSEMBLIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO RELATED NON-CONFORMANCE. THE CONTROL BARS WERE PACKAGED CORRECTLY PER PROCEDURE. DEVICE EVALUATION DETERMINED THAT THE CONTROL BARS DISPLAYED NICKS ALONG THE SURFACE AND THE LEADING EDGE OF THE COMPONENT. HOWEVER, THE TIMING OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    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 PATIENT USE AND THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191626 CONTROL BAR ASSEMBLY CONTROL BAR ASSEMBLY GFD ZIMMER SURGICAL NA 62267468

    Patients

    Seq Age Sex Outcome Treatment
    1