BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18580766 · Received January 25, 2024

    Report

    Report Number
    0001526350-2024-00146
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    September 8, 2023
    Report Date
    January 25, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    UDI-DI
    00889024375444
    PMA / PMN Number
    PREAMENDMEN
    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 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 HE CUTTER FAILED THE SAMPLE MESH TEST DUE TO AN INCOMPLETE MESH. THE CUTTER DOES NOT MEET THE ZIMMER TEST CUT ACCEPTANCE CRITERIA; HOWEVER, THE REPAIR WAS NOT COMPLETED BECAUSE CUTTERS ARE NOT REPAIRABLE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED. ADDITIONAL RELATED REPORTS: 0001526350-2023-01295-1. 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 MESHER IS BENT AND CAUSES INCOMPLETE MESH GRAFTS. THE EVENT OCCURRED DURING SURGERY. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. AT INVESTIGATION IT WAS NOTED THAT THE CUTTER FAILED THE SAMPLE MESH TEST DUE TO AN INCOMPLETE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888737 Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP ) EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 66016242 00889024375444

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose ITEM NUMBER00770303000SERIAL # (B)(6).