DRL BIT Q-C 2.7MM DIA 100MM

Description of Event or Problem

IT WAS REPORTED THAT A 2.7 MM DRILL BIT FROM A DISTAL FEMUR CUTTING KIT BROKE INTRA-OPERATIVELY DURING SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN - EVENT OCCURRED IN BRAZIL.. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - DRILL. 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.