BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMATOME BLADES

    MDR report key: 18999237 · Received March 28, 2024

    Report

    Report Number
    0001526350-2024-00395
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Report Date
    March 28, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; FUNCTIONAL, VISUAL, AND/OR DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, AND LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT CANNOT BE 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001526350-2023-01410-1 H3 OTHER TEXT : PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THE DERMATOME DID NOT PRODUCE AN EVEN GRAFT. IT WAS SKIPPING A CHUNK IN THE MIDDLE. THERE WAS NO INFORMATION PROVIDED REGARDING ANY PATIENT HARM OR SURGICAL DELAY THAT MAY HAVE OCCURRED. DURING DEVICE INVESTIGATION IT WAS DISCOVERED THAT THE BLADE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487727 DERMATOME BLADES DERMATOME GFD ZIMMER SURGICAL, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose