MalfunctionGDF
ZIMMER AIR DERMATOME
Received Feb 10, 2026 · Event occurred Feb 6, 2026
Report 0001526350-2026-00135 · MDR key 24302610
Device
Product problems
- Failure to Cut
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE THE SURGERY THE UNIT WAS NOT SHAVING CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.
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.