BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER TIBIAL PUNCH TOWER MOD

    MDR report key: 7751289 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-04543
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    June 15, 2018
    Report Date
    January 3, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWP
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF ACTUAL DEVICE RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED WITH NO DEVIATIONS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, ROOT CAUSE CAN BE DETERMINED AS NORMAL WEAR DURING THE INSTRUMENT'S FIELD LIFE. 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 WAS REPORTED THAT DURING A PROCEDURE, THE TIBIAL PUNCH TOWER BROKE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595187 PREMIER TIBIAL PUNCH TOWER MOD PUNCH, FEMORAL NECK HWP ZIMMER BIOMET, INC. N/A ZB090227

    Patients

    Seq Age Sex Outcome Treatment
    1