BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z.S.G.M. CUTTER 2:1 RATIO ( CAUTION: SHARP )

    MDR report key: 16157642 · Received January 13, 2023

    Report

    Report Number
    0001526350-2023-00063
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Report Date
    May 8, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    UDI-DI
    00889024375451
    PMA / PMN Number
    PREAMENDMENT
    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

    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: 0001526350-2023-00062, 0001526350-2023 00064.

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2023-00062-1 AND 0001526350-2023-00064-1. REVIEW OF THE MOST RECENT REPAIR RECORD IDENTIFIED THE FOLLOWING RELATED REPAIR: THE CUTTER FAILED TESTING DUE TO AN INCOMPLETE CUT. THE CUTTER WILL NEED REPLACEMENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE FAILED THE MESH TEST. THE EVENT TIMING WAS OUTSIDE OF SURGERY. 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.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964381 Z.S.G.M. CUTTER 2:1 RATIO ( CAUTION: SHARP ) SKIN GRAFT MESHER FZW ZIMMER SURGICAL, INC. UNK 64429468 00889024375451

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown