BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER MODULAR FLEX DRILL

    MDR report key: 6048718 · Received October 21, 2016

    Report

    Report Number
    0001822565-2016-03865
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 14, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. RETURNED DEVICE SHOWS SIGNS OF REPEATED USE. THE BIT IS FRACTURED BETWEEN THE END AND BASE OF THE FLUTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS

    Description of Event or Problem · 1

    IT IS REPORTED THAT BOTH DRILL BITS SNAPPED WHILE DRILLING INTO THE ACETABULUM. NO PIECES WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699474 ZIMMER MODULAR FLEX DRILL HIP INSTRUMENT HTW ZIMMER, INC. 63031381

    Patients

    Seq Age Sex Outcome Treatment
    1