ZIMMER AIR DERMATOME

Additional Manufacturer Narrative

THIS EVENT IS BEING RECORDED UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN CHINA. (B)(6). THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY THE DEVICE'S ACTUAL DEPTH DIFFERED SIGNIFICANTLY FROM THE SET DEPTH RESULTING IN A THINNER GRAFT. NO ADDITIONAL GRAFT OR HARM WAS NOTED. A FIVE MINUTE DELAY WAS NOTED. DILIGENCE IS COMPLETE.