BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z.S.G.M. CUTTER 3:1 RATIO ( CAUTION: SHARP )

    MDR report key: 16122290 · Received January 9, 2023

    Report

    Report Number
    0001526350-2023-00027
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Report Date
    January 23, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D4, D9, G3, G6, H2, H3, H4, H6, H10. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ALL ASSOCIATED REPORT(S): 0001526350-2023-00025-1, 0001526350-2023-00026-1, 0001526350-2023-00027-1. REVIEW OF THE MOST RECENT REPAIR RECORD IDENTIFIED THE FOLLOWING RELATED REPAIR: THE CUTTER FAILED THE TEST CUT WITH AN INCOMPLETE CUT. THE CUTTERS WERE RETURNED AS IS. 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.

    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.

    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. MEDWATCH ASSOCIATED WITH MESHER: 0001526350 - 2023 - 00025. MEDWATCH ASSOCIATED WITH OTHER CUTTER: 0001526350 - 2023 - 00026.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING PREVENTATIVE MAINTENANCE, THAT THE CUTTER FAILED THE CUT TEST. NO ADVERSE EVENTS WERE ASSOCIATED WITH THIS DEVICE. DUE DILIGENCE IS IN PROGRESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306243 Z.S.G.M. CUTTER 3:1 RATIO ( CAUTION: SHARP ) SKIN GRAFT MESHER FZW ZIMMER SURGICAL, INC. N/A 31029100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown