ZIMMER AIR DERMATOME
Received Jun 26, 2026 · Event occurred Jan 8, 2026
Report 0001526350-2026-00735 · MDR key 25635916
Device
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY ON (B)(6) 2026, THE MOTOR UNIT IS NOT WORKING. THERE WAS NO PATIENT IMPACT BUT IT IS UNKNOWN IF THERE WAS DELAY. DURING THE INVESTIGATION, IT WAS FOUND THAT IT HAD INCONSISTENT SPEED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Additional Manufacturer Narrative
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD IDENTIFIED THE FOLLOWING RELATED REPAIR: THE MOTOR WAS NOT WORKING, COULD NOT VERIFY RPMS TOO ERRATIC TO TEST. THE MOTOR, SWIVEL, NUT BEARING LOCK, SPRING, POPPET HOUSING, O-RING, SCREWS, HOUSING, SLEEVE MOTOR, PLANETARY SPACER, GEAR, E-RING, LEVER, PLANET GEAR, RECIPROCATION ARM, BALL BEARING AND NEEDLE BEARING WERE REPLACED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE 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.