BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER DERMATOME 1" WIDTH PLATE

    MDR report key: 17684865 · Received September 5, 2023

    Report

    Report Number
    0001526350-2023-01073
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    March 27, 2023
    Report Date
    September 27, 2023
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE WIDTH PLATES WERE DAMAGED. THE WIDTH PLATES WERE REPLACED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2023-00404-2, 0001526350-2023-01070-1, 0001526350-2023-01071-1, 0001526350-2023-01072-1.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2023-00404, 0001526350-2023-01070, 0001526350-2023-01071, 0001526350-2023-01072.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THE DERMATOME BLADE CAUSED A LACERATION ON THE PATIENT. NO ADDITIONAL DETAILS REGARDING THE LACERATION WERE PROVIDED. THERE WAS A DELAY OF AN UNKNOWN AMOUNT OF TIME AS ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE WIDTH PLATE WAS DAMAGED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378818 ZIMMER DERMATOME 1" WIDTH PLATE DERMATOME HANDPIECE, PNEUMATIC GFD ZIMMER SURGICAL, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other