BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMATOME BLADES

    MDR report key: 17894747 · Received October 9, 2023

    Report

    Report Number
    0001526350-2023-01290
    Event Type
    Injury
    Date Received
    October 9, 2023
    Date of Event
    September 9, 2023
    Report Date
    February 19, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    UDI-DI
    00889024375895
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001526350-2023-01288-2, 0001526350-2023-01291-2.

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001526350-2023-01288-1, 0001526350-2023-01291-1. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; FUNCTIONAL, VISUAL, AND/OR DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING AND DESIGN ISSUE. 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.

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2: FOREIGN: FRANCE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001526350-2023-01288, 0001526350-2023-01291. EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. H3 OTHER TEXT: DEVICE IS NOT BEING RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT POST-MORTEM EPIDERMAL SAMPLING THREE BLADES FROM THE SAME BATCH NUMBER WERE NOT VERY SHARP AND PRODUCED POOR SAMPLES. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT UNKNOWN TIMING THREE BLADES FROM THE SAME BATCH NUMBER WERE NOT VERY SHARP AND PRODUCED POOR SAMPLES. THERE HAS BEEN NO REPORT OF HARM OR DELAY. DUE DILIGENCE IS IN PROCESS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966802 DERMATOME BLADES DERMATOME GFD ZIMMER SURGICAL, INC. N/A 65223635 00889024375895

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose ELECTRIC DERMATOMEPN 00882100100SN UNK