BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 17236806 · Received June 30, 2023

    Report

    Report Number
    0001526350-2023-00667
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    May 18, 2023
    Report Date
    September 15, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    UDI-DI
    00889024375390
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE RATCHET HANDLE WOULD NOT MOVE UP AND DOWN. THE HANDLE WAS DISSEMBLED AND REASSEMBLED TO RESOLVE THE REPORTED ISSUE. 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.

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)4). THIS MEDWATCH IS BEING FILED AS AN INITIAL REPORT. TELEPHONE: (B)(6). JAPAN. 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 · 0

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RATCHET HANDLE DOES NOT MOVE UP AND DOWN. EVENT OCCURRED OUTSIDE SURGERY. THERE WAS NO REPORTED PATIENT INVOLVEMENT, HARM, OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988855 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 64303716 00889024375390

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose