BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER NATURAL NAIL SYSTEM 3.0 MM THREADED

    MDR report key: 2180729 · Received May 5, 2011

    Report

    Report Number
    1822565-2011-01119
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE THE SURGEON ATTEMPTED TO PLACE A 3MM GUIDE PIN IN THE RECON SCREW POSITION, THE PIN MISTARGETED AND BROKE OFF AT THE POINT WHERE THE THREADED PORTION ENDS. THE NAIL THAT HAD BEEN IMPLANTED HAD TO BE REMOVED SO THE BROKEN PIECE COULD BE RETRIEVED. THE NAIL WAS REINSERTED AND SCREWS WERE PLACED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER NATURAL NAIL SYSTEM 3.0 MM THREADED LXH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR