BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMATOME BLADES

    MDR report key: 18595702 · Received January 29, 2024

    Report

    Report Number
    0001526350-2024-00153
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    September 21, 2023
    Report Date
    January 29, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    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: 0001526350-2023-01345-1. D4 EXPIRATION DATE: UNKNOWN. THE INVESTIGATION IS COMPLETE. THIS IS AN INITIAL FINAL REPORT SUBMISSION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE DERMATOME CAUSED A FULL THICKNESS INJURY TO THE LEG OF THE PATIENT. THE SURGEON HAD TO STITCH TO CLOSE THE AREA, CAUSING ADDITIONAL SCARRING OF THE PATIENT. THERE WAS NO DELAY TO THE PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. AT INVESTIGATION IT WAS DETERMINED THAT THE DERMATOME BLADE MAY HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768817 DERMATOME BLADES DERMATOME GFD ZIMMER SURGICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Required Intervention