BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 18267279 · Received December 5, 2023

    Report

    Report Number
    0001526350-2023-01608
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 13, 2023
    Report Date
    May 20, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). E1 TELEPHONE: (B)(6). H10 ADDITIONAL REPORTS RAN FOR THIS REPORT: (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE DEVICE WAS MISSING A BEARING WHICH CAUSED CUTTING AND CALIBRATION ISSUES, AND THE COMB AND BOTTOM ROLL WERE DAMAGED. THE BEARING, COMB, AND BOTTOM ROLL WERE REPLACED AND RESOLVED THE REPORTED ISSUE. 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

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2 FOREIGN: UNITED KINGDOM. EVALUATION AND INVESTIGATION ARE IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING MAINTENANCE INSPECTION ON 13 NOV 2023, THE FOLLOWING FAILURE DESCRIPTIONS WERE NOTED: MISSING CE MARK; CALIBRATION ISSUE; DAMAGED COMB; WORN BOTTOM ROLL; MISSING BEARING; DEFECTIVE ACCESSORY RETURN: 1-1/2 - 111076; 2:1 - 805068. THERE WAS NO PATIENT INVOLVEMENT, IMPACT, OR HARM REPORTED AS DEVICE WAS ONLY RETURNED FOR PREVENTIVE MAINTENANCE. DUE DILIGENCE INFORMATION COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029682 ZIMMER SKIN GRAFT MESHER SKIN GRAFT MESHER FZW ZIMMER SURGICAL, INC. N/A 32592500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose