BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 22307177 · Received June 23, 2025

    Report

    Report Number
    0001526350-2025-00786
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    May 15, 2025
    Report Date
    November 18, 2025
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    UDI-DI
    00889024375901
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4 B5 D4 G3 G6 H2 H3 H4 H6 H11 COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THAT THE CONTROL BAR WAS LOOSE, AND NOT IN THE CORRECT POSITION. CALIBRATION WAS OUT AT THE 0 READINGS. SPRING PIN WAS NOT SEATED PROPERLY. POPPET SCREW WAS BENT. CARRIER PINS WERE NOT SEATED PROPERLY. BALL PLUNGER WAS NOT IN THE CORRECT POSITION. THERE WERE WORN AND DAMAGED COMPONENTS. THE BEARINGS, LEVER, BALL PLUNGER, HINGE THROTTLE GASKET, SCREW SEAL, AND SCREW WERE REPLACED AND RESOLVED THE REPORTED ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER CMP-0993924. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE DEVICE WAS UNABLE TO CUT A PROPER GRAFT AS IT WAS GOUGING. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732801 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 66694115 00889024375901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown