ZIMMER AIR DERMATOME

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY THE ACTUAL DEPTH OF THE DEVICE DIFFERS SIGNIFICANTLY FROM THE SET DEPTH AND IS TOO SHALLOW. THIS WAS NOT A CALIBRATION ISSUE. THE DEVICE PROVIDED AN INCORRECT OR INACCURATE MEASUREMENT/THICKNESS. THERE WAS NO PATIENT IMPACT. THERE WAS A 5-MINUTE DELAY. THE SURGERY WAS COMPLETED AFTER PROCESSING THE ORIGINAL SKIN GRAFT. NO ADDITIONAL GRAFT WAS NEEDED. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN EVENT OCCURRED IN CHINA. 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.