BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAN SPRAY KIT

    MDR report key: 16452313 · Received February 28, 2023

    Report

    Report Number
    0001526350-2023-00216
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    October 12, 2022
    Report Date
    February 28, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    UDI-DI
    00889024375161
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INCIDENT HAS BEEN RECORDED UNDER CMP-0844932. TELEPHONE: (B)(6). FUNCTIONAL TESTING FOUND THE DEVICE WOULD NOT POWER ON IN HIGH OR LOW MODE WITH THE ORIGINAL BATTERY PACK BUT DID POWER ON AND FUNCTIONED 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. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 WHEN SURGEON PULLED THE TRIGGER IN THE DEVICE TO SWITCH ON, THE DEVICE RAN BUT NOT SOMETIMES. NO HARM WAS REPORTED BUT A 0-15 MINUTE DELAY WAS NOTED. SUBSEQUENTLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT WAS REPORTED AS IT RELATES TO THIS EVENT. DURING EVALUATION, IT WAS DISCOVERED THAT THE BATTERIES WERE LEAKING. DUE DILIGENCE IS COMPLETE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787018 FAN SPRAY KIT DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM FQH ZIMMER SURGICAL, INC. N/A 65438003 00889024375161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown