BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 16708450 · Received April 10, 2023

    Report

    Report Number
    0001526350-2023-00353
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 7, 2023
    Report Date
    January 23, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE DEVICE WAS NOT CUTTING FULLY; THE COMB, CARRIER GUIDE, GEAR, AND SIDE PLATES WERE DAMAGED. THE COMB, CARRIER GUIDE, GEAR, AND SIDE PLATES WERE REPLACED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2023-00354-1.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. ASSOCIATED CUTTER MEDWATCH: 0001526350-2023-00354.

    Additional Manufacturer Narrative · 0

    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 OUTSIDE OF SURGERY, THE DEVICE WAS DULL AND DOES NOT FULLY PENETRATE THROUGH TISSUE. THE DEVICE HAD A DAMAGED COMB, CARRIER GUIDE, GEAR AND SIDE PLATES. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED OUTSIDE OF SURGERY, THAT THE DEVICE WAS DULL AND DOES NOT FULLY PENETRATE THROUGH TISSUE. NO HARM OR DELAY WERE NOTED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. NO ADVERSE EVENT WAS ASSOCIATED WITH THIS MALFUNCTION.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754057 ZIMMER SKIN GRAFT MESHER SKIN GRAFT MESHER FZW ZIMMER SURGICAL, INC. N/A 62367113

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose