BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIV LAG SCREW

    MDR report key: 1843351 · Received September 22, 2010

    Report

    Report Number
    2648920-2010-00046
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 30, 2010
    Manufacturer
    ZIMMER
    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 THE SURGEON HAD DIFFICULTY PUSHING THE GUIDE PIN THROUGH THE LAG SCREW. WHEN THE SURGEON PUSHED THE GUIDE PIN THROUGH THE LAG SCREW THERE WAS A METAL FRAGMENT THAT HAD TO BE REMOVED FROM THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIV LAG SCREW TRAUMA PROSTHESIS HWC ZIMMER 61480995

    Patients

    Seq Age Sex Outcome Treatment
    1