BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 22839923 · Received August 19, 2025

    Report

    Report Number
    0001526350-2025-01097
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 14, 2025
    Report Date
    January 15, 2026
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    UDI-DI
    00889024375901
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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, G3, G6, H2, H6 AND H11. 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 TRENDS.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). FOLLOWING SECTIONS WERE UPDATED OR CORRECTED: B4, B5, D4, D9, G3, G6, H2, H3, H4, H6 AND H11. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE RECIPROCATING ARM WAS JUMPING BUT THE MOTOR RPMS WERE WITHIN SPECIFICATIONS, THE MOTOR, RECIPROCATING ARM, AND NEEDLE BEARING WERE CORRODED, THE CONTROL LEVER BALL PLUNGER WAS WORN, THE LEVER, SWIVEL, AND CONTROL BAR WERE LOOSE, AND THE CONTROL BAR WAS NOT IN THE CORRECT POSITION. THE MOTOR, SLEEVE, ECCENTRIC SHAFT, SWIVEL, LEVER, BALL PLUNGER, DOWEL PIN, POPPET SPRING, PLANETARY CARRIER, PLANETARY GEAR, HINGE THROTTLE GASKET, O-RING, SCREW SEAL, SCREWS, BEARING SPACER, AND BEARINGS 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. 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 TRENDS.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER CMP-1002552. 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

    IT WAS REPORTED THAT BEFORE SURGERY, DURING TESTING, THE UNIT WAS NOT RUNNING SMOOTHLY, IT WAS JUMPING AND INTERMITTENT. THERE WAS NO PATIENT INVOLVED. DUE DILIGENCE IS COMPLETE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN TIME, ON (B)(6), 2025, THE UNIT WAS NOT RUNNING SMOOTHLY, IT WAS JUMPING AND INTERMITTENT. THERE WAS NO PATIENT IMPACT OR DELAY REPORTED. DUE DILIGENCE IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282590 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 66995358 00889024375901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown