BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 22867416 · Received August 21, 2025

    Report

    Report Number
    0001526350-2025-01113
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 29, 2025
    Report Date
    January 20, 2026
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    UDI-DI
    00889024375901
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 MOTOR WAS LOUD AND WHINY BUT THE RPMS WERE WITHIN SPECIFICATIONS, THE RECIPROCATING ARM, PLANETARY PINS, AND POPPET GASKET WERE DAMAGED, THE NEEDLE BEARING, MOTOR, AND BALL BEARINGS WERE WORN, THE RECIPROCATING ARM AND NEEDLE BEARING WERE CORRODED, THE SWIVEL AND CONTROL BAR WERE LOOSE, AND THE CONTROL BAR AND PLANETARY PINS WERE NOT IN THE CORRECT POSITION. THE MOTOR, SLEEVE, SWIVEL, HINGE THROTTLE GASKET, SPRING PINS, SPRING, BEARINGS, DOWEL PINS, PLANETARY CARRIER, SCREW SEAL, AND SCREWS WERE REPLACED AND RESOLVED THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED EVENT WAS 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 CMP-1003419. 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 SURGERY THE DEVICE SKIPPED QUICKLY OVER THE SKIN. NITROGEN WAS USED PROPERLY. 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
    2203514 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 66799188 00889024375901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown