ZIMMER AIR DERMATOME

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 STOPS WORKING INTERMITTENTLY AND MAKES AN ODD SOUND WHILE IN USE. THERE WAS NO PATIENT IMPACT BUT IT IS UNKNOWN IF THERE WAS DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.