BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER NATURAL NAIL TIBIAL NAIL

    MDR report key: 2093286 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01096
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    February 10, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AS THE SURGEON PLACED THE TIBIAL NAIL OVER THE BALL TIPPED GUIDE WIRE, HE NOTICED A CLUMP OF DEBRIS THAT CAME OUT OF THE CANNULATED PORTION OF THE TIBIAL NAIL. IT SEEMS THE GUIDE WIRE DISLODGED THIS DEBRIS THAT WAS ALLEGEDLY INSIDE OF THE TIBIAL NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER NATURAL NAIL TIBIAL NAIL HSB ZIMMER, INC. 61283853

    Patients

    Seq Age Sex Outcome Treatment
    1