ZIMMER AIR DERMATOME, COMPLETE

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN, EVENT OCCURRED IN CANADA. 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 UNIT HAD AN AIR LEAK FROM THE HANDHELD DEVICE. THERE WAS NO PATIENT IMPACT A DELAY OF A FEW MINUTES OCCURRED WHILE LOOKING FOR ANOTHER DEVICE. NO ADDITIONAL SKINGRAFT WAS REQUIRED. DUE DILIGENCE IS COMPLETE AS NO FURTHER INFORMATION IS AVAILABLE.