BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPONENT KIT

    MDR report key: 18074114 · Received November 6, 2023

    Report

    Report Number
    0001526350-2023-01448
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 11, 2023
    Report Date
    April 25, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    UDI-DI
    00889024375123
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER CMP-0902465. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2023-01449, 0001526350-2023-01450, 0001526350-2023-01451.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). A TOTAL OF 4 DEVICES WERE RETURNED. ONLY ONE WAS OPENED. FUNCTIONAL TESTING FOUND THE OPENED DEVICE WOULD NOT POWER ON WITH THE ORIGINAL BATTERY PACK BUT DID POWER ON AND FUNCTION NORMALLY IN BOTH MODES WHEN CONNECTED TO A LAB BATTERY PACK. VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. THE OTHER 3 WERE SEALED IN PACKAGE AND HAD NO VISIBLE DAMAGE OR ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO MANUFACTURING PROCESS. THE EVENT IS CONFIRMED. 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

    IT WAS REPORTED THAT DURING SURGERY THE BATTERY WAS LEAKING ACID UPON OPENING. THERE WAS NO PATIENT HARM AND NO DELAY NOTED. AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951958 COMPONENT KIT LAVAGE, JET FQH ZIMMER SURGICAL, INC. N/A 70849494 00889024375123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose