BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER TIBIAL PUNCH TOWER MOD

    MDR report key: 8339859 · Received February 14, 2019

    Report

    Report Number
    0001825034-2019-00552
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 21, 2019
    Report Date
    August 8, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL INSPECTION OF THE PHOTOGRAPHS PROVIDED SHOWS THAT THE KNOB, SPRING AND CATCH PLATE HAVE DISASSEMBLED FROM THE MAIN PUNCH TOWER ASSEMBLY WHICH IS NORMALLY CONNECTED BY THE SCREW AND THERE IS POSSIBILITY THAT THE SCREW FRACTURED AND THE PARTS DISASSEMBLED. HOWEVER, IT IS UNKNOWN IF THE SCREW IS FRACTURED OR NOT. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE CANNOT BE DETERMINED. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING A PROCEDURE. NO PIECES OF THE INSTRUMENT FELL INTO THE PATIENT'S WOUND. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131364 PREMIER TIBIAL PUNCH TOWER MOD PROSTHESIS, KNEE HWP ZIMMER BIOMET, INC. NI ZB160301

    Patients

    Seq Age Sex Outcome Treatment
    1