BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDI FLOW FILTER SYS CMPL 6/CS

    MDR report key: 8572658 · Received May 2, 2019

    Report

    Report Number
    0001825034-2019-02012
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    March 29, 2019
    Report Date
    October 31, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    GAZ
    PMA / PMN Number
    K790209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. CORRECTIVE ACTIONS HAVE BEEN INITIATED TO ADDRESS THIS ISSUE. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). FDA PRODUCT CODE: GAZ. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PIECE IN THE END OF THE INSTRUMENT FELL OUT INTO THE PATIENT. IT WAS RETRIEVED AND A DIFFERENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367951 REDI FLOW FILTER SYS CMPL 6/CS TRAUMA, INSTRUMENT GAZ ZIMMER BIOMET, INC. 220806

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R