ZIMMER AIR DERMATOME, COMPLETE

Additional Manufacturer Narrative

THIS EVENT IS BEING RECORDED UNDER (B)(4). G2: FOREIGN. EVENT OCCURRED IN CANADA. E1: TELEPHONE. (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 A PROCEDURE A SPLIT THICKNESS SKIN GRAFT WAS TO BE TAKEN INTRAOPERATIVELY. THE DERMATOME WAS PLACED ON THE CORRECT SETTING/DEPTH AS CONFIRMED BY SURGICAL TEAM BUT UPON USE WAS FOUND TO HAVE TAKEN MORE SKIN THAN EXPECTED. ANOTHER DERMATOME WAS ORDERED TO THE ROOM AND WAS FOUND TO BE WORKING CORRECTLY. NO FURTHER PATIENT HARM REPORTED. PROLONGED CARE WAS NOTED. DILIGENCE IS COMPLETE.