BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER NEXEL TOTAL ELBOW T-HANDLE

    MDR report key: 6042080 · Received October 19, 2016

    Report

    Report Number
    0001822565-2016-03805
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    March 23, 2016
    Report Date
    April 1, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. RECEIVED, BUT NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. HARDNESS AND DIMENSIONS TAKEN ARE WITHIN SPECIFICATION. THE HANDLE HAS HEAVY GOUGES. REVIEW OF THE RECEIVING INSPECTION REPORT DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE COMPLAINANT DESCRIBED BURR'S AS METAL SHAVINGS. THE T-HANDLE WAS MANUFACTURED ON NOV 15, 2013 AND THEREFORE HAS A POTENTIAL FIELD AGE OF 2 YEARS 4 MONTHS. THE FREQUENCY OF USE OF THE DEVICE IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. THE STRIKE MARKS CONFIRMS THAT THE DEVICE HAS BEEN EXTENSIVELY USED. THE INSTRUCTIONS FOR USE INCLUDED WITH THE DEVICE STATES, ¿IF DAMAGE OR WEAR IS NOTED THAT MAY COMPROMISE THE FUNCTION OF THE INSTRUMENT, DO NOT USE THE DEVICE AND CONTACT YOUR ZIMMER REPRESENTATIVE FOR A REPLACEMENT.¿ A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THE T-HANDLE WAS DAMAGED WHILE HAMMERING. METAL SHAVINGS CAME OFF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691474 ZIMMER NEXEL TOTAL ELBOW T-HANDLE EXTREMITY INSTRUMENT JDC ZIMMER, INC. 62535064

    Patients

    Seq Age Sex Outcome Treatment
    1