BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 14517594 · Received May 26, 2022

    Report

    Report Number
    0001526350-2022-00508
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    May 11, 2022
    Report Date
    August 23, 2022
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    UDI-DI
    00889024375901
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). D4: THERE WERE 7 DEVICE IDS PROVIDED BY THE CUSTOMER FOR THIS EVENT; OF THESE 7, ONLY 1 WAS REPORTED TO BE CAUSING A GOUGING OF THE PATIENT WHEN USED AND THE SKIN REQUIRED SUTURES. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE. IT IS ONE OF THE FOLLOWING: ITEM NUMBER OF ALL 7: 00880100100. LOT NUMBER OF ALL 7: 65415179. THE LIST OF THE 7 SERIAL NUMBERS: (B)(6). 510(K): EXEMPT. EU CLASS CODE: IIB. US CLASS CODE: I. UDI: (B)(4). PRODUCT CODE: GFD. MEDICAL DEVICE LISTING: C041134. THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. REVIEW OF THE MOST RECENT REPAIR RECORD IDENTIFIED NO REPAIRS RELATED TO THE REPORTED EVENT. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE DERMATOME CAUSED GOUGING OF THE PATIENT AND THE SKIN REQUIRED SUTURES. NO ADDITIONAL CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2755266 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. N/A 65415179 00889024375901

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female