BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SELF-TAPPING BONE SCREW

    MDR report key: 6142791 · Received December 2, 2016

    Report

    Report Number
    0002648920-2016-03326
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Report Date
    October 15, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    PK840643
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2016-03327-1.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON INSERTING THE BONE SCREWS, THE HEAD FRACTURED OFF. THE SCREW WAS ALREADY IN THE PATIENT, THEREFORE NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792325 ZIMMER SELF-TAPPING BONE SCREW HIP PROSTHESIS JDI ZIMMER MANUFACTURING B.V. N/A 63276976

    Patients

    Seq Age Sex Outcome Treatment
    1