ZIMMER AIR DERMATOME
Received Jun 10, 2026 · Event occurred May 6, 2026
Report 0001526350-2026-00649 · MDR key 25458902
Device
Product problems
- Unstable
Patient
Unknown
- Laceration(s)
- Graft failure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY, THE UNIT JUMPED/SKIPPED WHEN IT CAME INTO CONTACT WITH THE SKIN. IT CAUSED A SMALL GOUGE IN THE PATIENT, ALTHOUGH IT WAS NOT DEEP. THE TAKEN GRAFT WAS DAMAGED, AND AN ADDITIONAL GRAFT HAD TO BE TAKEN. THERE WAS PATIENT IMPACT, AND A SMALL DELAY OCCURRED DUE TO THE PREPARATION OF A BACKUP PRODUCT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION 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.