BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER TIBIAL PUNCH TOWER MOD

    MDR report key: 8555020 · Received April 26, 2019

    Report

    Report Number
    0001825034-2019-01823
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    February 4, 2019
    Report Date
    October 1, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMS IT HAS FRACTURED INTO 2 PIECES. HALF OF THE FRACTURED SCREW IS STILL ATTACHED TO THE TOWER. THE DEVICE WAS RECEIVED DISASSEMBLED. SEM ANALYSIS OF THE FLAT SOCKET CAP SCREW IN THE TIBIAL TOWER ASSEMBLY SHOWED THAT IT FRACTURED DUE TO BENDING OVERLOAD. EDS SEMI-QUANTITATIVE ELEMENTAL ANALYSIS OF THE FLAT SOCKET CAP SCREW SAMPLE SHOWED THAT IT WAS CONSISTENT WITH 17-4 PH STAINLESS STEEL. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADED SCREW BROKE OFF THE TOWER WHEN DRILLING THE TIBIAL. NO PIECES OF THE INSTRUMENT FELL INTO THE PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348528 PREMIER TIBIAL PUNCH TOWER MOD INSTRUMENT, KNEE HWP ZIMMER BIOMET, INC. N/A ZB160704

    Patients

    Seq Age Sex Outcome Treatment
    1