BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 16157653 · Received January 13, 2023

    Report

    Report Number
    0001526350-2023-00062
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Report Date
    May 8, 2023
    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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2023-00063-1 AND 0001526350-2023-00064-1. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE PRE-TEST COULD NOT BE PERFORMED DUE TO A DAMAGED COMB. THE COMB WAS REPLACED AND RESOLVED THE REPORTED ISSUE. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. 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 COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). A FOLLOW UP/ FINAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2023-00063. 0001526350-2023-00064.

    Description of Event or Problem · 0

    THERE IS NO EVENT INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COMB IS BENT. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THEREFORE, THERE WAS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186172 ZIMMER SKIN GRAFT MESHER SKIN GRAFT MESHER FZW ZIMMER SURGICAL, INC. UNK 61396391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown