MalfunctionGFD
ZIMMER AIR DERMATOME
Received Jun 23, 2026 · Event occurred May 26, 2026
Report 0001526350-2026-00711 · MDR key 25593425
Device
Product problems
- Loose or Intermittent Connection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE SCREWS WOULD NOT FLUSH INTO DEVICE, THE UNIT COULD NOT BE USED WITHOUT PROPER SCREWS. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.