MalfunctionGFD
ZIMMER AIR DERMATOME
Received Jul 2, 2026 · Event occurred Jun 17, 2026
Report 0001526350-2026-00771 · MDR key 25690834
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 HANDPIECE WAS SKIPPING, ONLY ABLE TO HARVEST SMALL SAMPLES OF SKIN UNSUITABLE FOR GRAFTING. THERE WAS NO PATIENT IMPACT OR DELAY REPORTED. DUE DILIGENCE IS IN PROGRESS.
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN CANADA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.