BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMATOME BLADES

    MDR report key: 18011325 · Received October 26, 2023

    Report

    Report Number
    0001526350-2023-01400
    Event Type
    Injury
    Date Received
    October 26, 2023
    Date of Event
    August 29, 2023
    Report Date
    November 28, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    UDI-DI
    00889024375895
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    ZFA 2023-00208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). 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. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR - 0001526350 - 2023 - 01401-1. MFR - 0001526350 - 2023 - 01212-2.

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE PRODUCT IS IN THE PROCESS OF BEING EVALUATED BY ZIMMER BIOMET. ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR - 0001526350 - 2023 - 01401, MFR - 0001526350 - 2023 - 01212.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THAT THE DERMATOME BLADES HAD AN ISSUE. THERE WAS HARM TO THE PATIENT AS DEEPER AND ADDITIONAL CUTS HAD TO BE MADE IN A DIFFERENT SPOT FROM WHERE THEY STARTED IN ORDER TO COMPLETE THE PROCEDURE. ANOTHER BLADE WAS USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579300 DERMATOME BLADES DERMATOME BLADE, SINGLE-USE GFD ZIMMER SURGICAL, INC. N/A 65972711 00889024375895

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| O UNKNOWN ZIMMER BIOMET.DERMATOME.