BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )

    MDR report key: 18443018 · Received January 4, 2024

    Report

    Report Number
    0001526350-2024-00018
    Event Type
    Malfunction
    Date Received
    January 4, 2024
    Date of Event
    July 25, 2023
    Report Date
    January 4, 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
    AS
    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). G2 FOREIGN: AUSTRALIA MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT(S): 0001526350-2023-01052-1, 0001526350-2024-00019, 0001526350-2024-00020 THE INVESTIGATION IS COMPLETE. THIS IS AN INITIAL FINAL REPORT SUBMISSION. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE CUTTER FAILED THE SAMPLE MESH TEST DURING EVALUATION DUE TO BLUNT SPOTS. THE CUTTER IS NOT REPAIRABLE AND WAS RETURNED TO THE CUSTOMER AS IS. 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. 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 BEFORE SURGERY THE DEVICE WAS SHREDDING SKIN GRAFT. THERE WAS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION DUE DILIGENCE IS COMPLETE. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER FAILED THE SAMPLE MESH TEST DURING EVALUATION DUE TO BLUNT SPOTS. NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558788 Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP ) EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 61968525

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose