BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17499971 · Received August 10, 2023

    Report

    Report Number
    0001526350-2023-00897
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    March 3, 2023
    Report Date
    August 10, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    UDI-DI
    00889024375444
    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: 0001526350-2023-00254-1. THE INVESTIGATION IS COMPLETE. THIS IS AN INITIAL FINAL REPORT SUBMISSION REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE CUTTER FAILED THE CUT TEST. CUTTERS ARE NOT REPAIRABLE AND IT WAS RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS CONFIRMED THE CUTTER FAILED THE CUT TEST. 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 THE UNIT IS NOT RATCHETING. IT WAS UNABLE TO PERFORM THE UP AND DOWN MOTION. THERE WAS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER FAILED THE CUT TEST. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091083 Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP ) EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 63704624 00889024375444

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose