BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TIV LAG SCREW

    MDR report key: 2122003 · Received May 24, 2011

    Report

    Report Number
    2648920-2011-00029
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ZIMMER
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT WAS SUBMITTED UNDER INCORRECT FDA MANUFACTURER #. PLEASE REFERENCE MEDWATCH REPORT #1822565-2011-01107. EVALUATION SUMMARY: THE MOST LIKELY CAUSE FOR THE FRAGMENT FOUND WITHIN THE LAG SCREW IS BECAUSE OF THE SEQUENCE IN WHICH THE INTERNAL CANNULATION AND THREADS WERE MACHINED. AT THE TIME THIS DEVICE WAS MANUFACTURED, THE INNER CANNULATION WAS MACHINED AND THEN THE THREADS POTENTIALLY ALLOWING FOR THE ACCUMULATION OF DEBRIS WITHIN THE CANNULATION. THE PROCESS WAS CHANGED IN (B)(6) 2010 (PRIOR TO RECEIVING ANY COMPLAINTS) TO WHERE THE THREADS ARE MACHINED FIRST AND THEN THE CANNULATION. THE CHANGE IN PROCESS SHOULD PREVENT ANY FURTHER ACCUMULATION OF DEBRIS WITHIN THE LAG SCREW. IN ADDITION, AFTER THE INNER FEATURES ARE MACHINED, THERE ARE SEVERAL WASHING AND FUNCTIONAL TESTING STEPS TO VERIFY THAT THE INNER CANNULATION IS FREE FROM DEBRIS. EVALUATION: THE RETURNED FRAGMENT WAS REVIEWED USING ENERGY DISPERSIVE SPECTROSCOPY (EDS) AND FOUND TO EXHIBIT A SPECTRUM SIMILAR TO THAT OF TIVANIUM ALLOY, CORRESPONDING WITH THE MATERIAL FROM WHICH THE LAG SCREW IS MANUFACTURED. TIVANIUM IS AN IMPLANTABLE MATERIAL. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    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 61295944

    Patients

    Seq Age Sex Outcome Treatment
    1