BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMATOME BLADES

    MDR report key: 17690561 · Received September 6, 2023

    Report

    Report Number
    0001526350-2023-01086
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    July 24, 2023
    Report Date
    January 12, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    UDI-DI
    00889024380318
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    ZFA 2023-00208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ADDITIONAL REPORT WAS CREATED UNDER: 0001526350-2023-01085-1. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A DESIGN ISSUE AND A MANUFACTURING ISSUE. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001526350-2023-01085. EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. H3 OTHER TEXT : DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY WHEN THE SURGEON WAS TAKING THE SKIN GRAFT, THE GRAFT HAD A CUT DOWN THE MIDDLE. AN ADDITIONAL GRAFT WAS TAKEN FROM THE PATIENT INCREASING SURGERY TIME. NO ADDITIONAL CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY WHEN THE SURGEON WAS TAKING THE SKIN GRAFT, THE GRAFT HAD A CUT DOWN THE MIDDLE. NO HARM OR DELAY WAS REPORTED. DUE DILIGENCE IS IN PROCESS. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455446 DERMATOME BLADES DERMATOME GFD ZIMMER SURGICAL, INC. N/A 65952858 00889024380318

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention AIR DERMATOMEPN 00880100100SN UNKNOWN