ZIMMER AIR DERMATOME
Received Jul 7, 2026 · Event occurred Jun 11, 2026
Report 0001526350-2026-00784 · MDR key 25728779
Device
Product problems
- Incorrect Measurement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY, THE ACTUAL DEPTH OF THE DEVICE DIFFERS SIGNIFICANTLY FROM THE SET DEPTH AND IS TOO SHALLOW. THERE WAS NO PATIENT HARM. THERE WAS NO MEDICAL INTERVENTION. THERE WAS NO ADDITIONAL SKIN GRAFT. THERE WAS A 5 - MINUTE SURGICAL DELAY. ANOTHER DEVICE WAS NOT REQUIRED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION 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. G2: FOREIGN - EVENT OCCURRED IN CHINA.