MalfunctionGFD
ZIMMER AIR DERMATOME
Received Apr 20, 2026
Report 0001526350-2026-00466 · MDR key 24925317
Device
Product problems
- Incorrect Measurement
Patient
Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THIS EVENT IS BEING RECORDED UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN CANADA. THE DEVICE WILL BE RETURNED FOR ANALYSIS, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE DEPTH SETTING IS NOT ACCURATE. GAUGE READ 12 BUT STILL TOOK A FULL THICKNESS GRAFT. IT IS UNKNOWN IF THERE WAS ANY PATIENT IMPACT AND DILIGENCE IS COMPLETE.