MalfunctionGFD
ZIMMER AIR DERMATOME
Received Apr 20, 2026 · Event occurred Apr 9, 2026
Report 0001526350-2026-00464 · MDR key 24925298
Device
Product problems
- Failure to Cut
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THIS INCIDENT IS BEING RECORDED UNDER (B)(4). E1: TELEPHONE: (B)(6). G2: FOREIGN: AUSTRALIA. ONCE INVESTIGATION IS COMPLETE A SUPPLEMENTAL/FINAL REPORT WILL BE SUBMITTED. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY THE DEVICE WAS NOT CUTTING PROPERLY. IT IS UNKNOWN IF THERE WAS ANY PATIENT IMPACT OR SURGICAL DELAY. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION WAS NOTED.