MalfunctionGFD
ZIMMER AIR DERMATOME
Received Jun 1, 2026
Report 0001526350-2026-00621 · MDR key 25354893
Device
Product problems
- Unstable
- Material Deformation
- Naturally Worn
- Noise, Audible
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE WAS RETURNED FOR PREVENTATIVE MAINTENANCE. DEVICE WAS TOO ERRATIC TO TEST THE RPMS AND EXCESSIVELY NOISY. NEED TO REPLACE SWIVEL MOTOR AND ALL WORN OR DAMAGED COMPONENTS. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
(B)(4). 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.