MalfunctionGFD
ZIMMER AIR DERMATOME
Received Apr 27, 2026 · Event occurred Mar 23, 2026
Report 0001526350-2026-00503 · MDR key 25008068
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 DURING SURGERY, THE BLADE DOESN'T ENGAGE AND NOT ABLE TO TAKE ANY SKIN. THERE WAS NO PATIENT IMPACT. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER CMP-(B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER.