MalfunctionGFD
ZIMMER AIR DERMATOME
Received Jun 11, 2026 · Event occurred May 5, 2026
Report 0001526350-2026-00655 · MDR key 25473992
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 A CUTTING DEVICE WAS NOT CUTTING PROPERLY. THE ISSUE WAS IDENTIFIED OUTSIDE OF SURGERY. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). 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.