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. G2: FOREIGN - EVENT OCCURRED IN CANADA.

Description of Event or Problem

IT WAS REPORTED THAT BEFORE SURGERY, THERE WAS AN AIR LEAK COMING FROM THE HANDPIECE. THERE WAS NO PATIENT IMPACT, BUT A DELAY OF APPROXIMATELY 5 - 7 MINUTES OCCURRED DUE TO THE PREPARATION OF A BACKUP PRODUCT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.