BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17232488 · Received June 29, 2023

    Report

    Report Number
    0001526350-2023-00664
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Report Date
    June 29, 2023
    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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED AS AN INITIAL / FINAL REPORT BASED ON INFORMATION DISCOVERED DURING THE DEVICE EVALUATION. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED CUTTER CREATING AN INCOMPLETE CUT. GEARS AND COLLARS WERE REPLACED 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. ADDITIONAL REPORTS: 0001526350-2023-00265-1; 0001526350-2023-00663. 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 UNIT WAS PRODUCING INCOMPLETE MESHES. AT EVALUATION THE INVESTIGATION FOUND THE CUTTER ALSO PRODUCES INCOMPLETE MESHES. THERE WAS NO REPORTED PATIENT INVOLVEMENT, HARM, OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254094 Z.S.G.M. CUTTER 2:1 RATIO ( CAUTION: SHARP ) EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 62779660

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose