ZIMMER AIR DERMATOME
Received Jul 9, 2026 · Event occurred Dec 18, 2025
Report 0001526350-2026-00805 · MDR key 25762201
Device
Product problems
- Failure to Power Up
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS INCIDENT IS BEING RECORDED UNDER (B)(4) AS AN INITIAL FINAL REPORT. G2: FOREIGN- JAPAN (B)(6). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE DEVICE WOULD NOT POWER ON AS IT WAS LEAKING AIR. THE MOTOR, SCREW SEAL, SPRING SEAL, BEARINGS, AND HINGE THROTTLE GASKET WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE REPORTED EVENT IS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING KIT INSPECTION THE UNIT DID NOT TURN ON. NO PATIENT INVOLVEMENT. UPON DEVICE EVALUATION IT WAS NOTED THAT THE DEVICE WAS LEAKING AIR. DILIGENCE IS COMPLETE.