ZIMMER AIR DERMATOME
Received Jul 2, 2026 · Event occurred May 18, 2026
Report 0001526350-2026-00773 · MDR key 25692526
Device
Product problems
- Corroded
- Failure to Cut
- Naturally Worn
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 DURING SURGERY, THE UNIT WAS JUMPY, AND THE DEVICE WAS SKIPPING. FURTHER INVESTIGATION REVEALED THAT THE MOTOR WAS CORRODED ONTO THE SWIVEL. THE NEEDLE BEARING, RECIPROCATING ARM, NECK PIN, AND SPRING SEAL WERE WORN AND CORRODED. THERE WAS NO PATIENT IMPACT BUT IT IS UNKNOWN IF THERE WAS DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.