BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TIV LAG SCREW

    MDR report key: 2093264 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01107
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE 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 WHEN PUSHING THE GUIDE PIN THROUGH THE LAG SCREW, A METAL FRAGMENT CAME OUT OF THE LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TIV LAG SCREW TRAUMA PROSTHESIS HWC ZIMMER INC 61295944

    Patients

    Seq Age Sex Outcome Treatment
    1