BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II INSTRUMENT ONLY

    MDR report key: 16901648 · Received May 10, 2023

    Report

    Report Number
    0001526350-2023-00453
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 2, 2023
    Report Date
    September 12, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    UDI-DI
    00889024372535
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2 FOREIGN: JAPAN. THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE RATCHET HANDLE WOULD NOT MOVE UP OR DOWN. THE RATCHET HANDLE WAS DISASSEMBLED AND ADJUSTED AND RESOLVED 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 HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT KIT INSPECTION THE RATCHET HANDLE OF THE MESHER WOULD NOT MOVE UP AND DOWN. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231898 MESHGRAFT II INSTRUMENT ONLY EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 65195513 00889024372535

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose