BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 17825440 · Received September 27, 2023

    Report

    Report Number
    0001526350-2023-01222
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    September 1, 2023
    Report Date
    January 25, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD COULD NOT BE COMPLETED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND REPAIR. LOT/SERIAL IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, AND LOT/SERIAL IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT CANNOT BE CONFIRMED. ADDITIONAL RELATED REPORTS: 0001526350-2023-01221-1. 0001526350-2023-01223-1. 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.

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER CMP-(B)(4). THIS MEDWATCH IS BEING FILED AS AN INITIAL REPORT. ADDITIONAL REPORTS: 0001526350-2023-01221 0001526350-2023-01223 CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. H3 OTHER TEXT : DEVICE NOT YET RETURNED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION IS AVAILABL.E

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DERMATOMES HAND PIECES HAD ISSUES WITH HARVESTING CORRECT SKIN THICKNESS. THE EVENT OCCURRED DURING SURGERY. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. DUE DILIGENCE IS IN PROGRESS, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097929 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose