ZIMMER AIR DERMATOME
Received May 22, 2026
Report 0001526350-2026-00602 · MDR key 25255155
Device
Product problems
- Loose or Intermittent Connection
- Material Deformation
- Naturally Worn
- Output below Specifications
- Positioning Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY DURING MAINTENANCE, THE UNIT RAN BELOW RPM SPEC, THE CONTROL BAR WAS LOOSE, THE CALIBRATIONS WERE IN AT ALL READINGS. THE DEVICE WAS RUNNING BELOW RPM SPECIFICATION THE LONGER IT RAN, AND IT NEEDS A NEW MOTOR AND OTHER WORN OR DAMAGED PARTS. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET. ONCE THE PRODUCT IS RETURNED AND THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.