ZIMMER AIR DERMATOME
Received Jul 15, 2026 · Event occurred Jun 3, 2026
Report 0001526350-2026-00842 · MDR key 25826354
Device
Product problems
- Unstable
Patient
NA · Unknown
- Laceration(s)
- Graft failure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY, THE UNIT SKIPPED ALONG TISSUE. THE TAKEN GRAFT WAS DAMAGED AND DISCARDED. AN ADDITIONAL UNPLANNED SKIN GRAFT WAS NEEDED IN ORDER TO COMPLETE THE SURGERY. THERE WAS A SURGICAL DELAY OF 5 MINUTES WHILE THEY SETUP ANOTHER DERMATOME. THERE WAS NO UNEXPECTED MEDICAL INTERVENTION NEEDED. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (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 CANADA.