HANDPIECE, ELECTRIC DERMATOME

Additional Manufacturer Narrative

THIS EVENT IS RECORDED BY (B)(4). G2: FOREIGN - EVENT OCCURRED IN FINLAND. 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 OPERATED ABNORMALLY. WHEN HARVESTING SKIN, THE ADJUSTMENT DID NOT WORK AND TOOK SKIN TOO THICKLY. THERE WAS A 10-MINUTE PROCEDURE DELAY. AN ADDITIONAL GRAFT WAS REQUIRED DURING THE PROCEDURE. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION