BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 23180282 · Received September 30, 2025

    Report

    Report Number
    0001526350-2025-01254
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Report Date
    March 26, 2026
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    UDI-DI
    00889024375901
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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). FOLLOWING SECTIONS WERE UPDATED OR CORRECTED: B4, B5, D2, D4, D9, G1, G3, G6, H1, H2, H3, H4, H6, AND H11. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE SKIPPING ISSUE WAS UNABLE TO BE CONFIRMED. THE UNIT WAS FOUND TO BE MISSING SCREWS. THE SPRING SEAL WAS CORRODED. THERE WAS CORROSIVE DUST INSIDE THE HEAD AND ON THE SWIVEL AND NEEDLE BEARING. THE NEEDLE BEARING AND ECCENTRIC SHAFT WERE CORRODED. THE POPPET ASSEMBLY WAS NOT FLUSH WITH THE HANDLE. THE SWIVEL WAS LOOSE. THE MOTOR WAS CORRODED ONTO THE SWIVEL. THE PLANETARY CARRIER, BEARINGS, AND GEARS WERE RUSTY AND CORRODED. THERE WAS A WHINING NOISE WHILE THE MOTOR WAS RUNNING. RPMS WERE IN SPECIFICATION. THE CONTROL BAR WAS LOOSE AND NOT IN POSITION. THE CALIBRATIONS WERE OUT A THE 0, 10, AND 20 READINGS. THE SWIVEL, POPPET ASSEMBLY GASKET, LEVER, NEEDLE BEARING, NUT BEARING LOCK, SPRING SEAL, BEARINGS, ECCENTRIC SHAFT, AND PLANETARY CARRIER ASSEMBLY WERE ALL REPLACED. NEW VESPELS AND SEMI-CIRCLES WERE INSTALLED. THE CONTROL BAR WAS ADJUSTED. ALL OTHER WORN OR DAMAGED COMPONENTS WERE REPLACED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO COMPONENT FAILURE AS THE DEVICE EXHIBITS WEAR AND TEAR FROM REPEATED USE. THE REPORTED EVENT WAS NOT 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

    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.

    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 TESTING, THE UNIT WAS SKIPPING. THERE WAS NO PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837960 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 66472343 00889024375901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown