3.2MMX50MM RNGLC+ ACET DRL BIT

Additional Manufacturer Narrative

(B)(4). PROPOSED CODE, MECHANICAL (G04), DRILL. G2: FOREIGN, EVENT OCCURRED IN SWITZERLAND. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE DRILL BIT BROKE OFF APPROXIMATELY 10¿15 MM FROM THE DISTAL TIP DURING DRILLING. THE REPORTER ATTEMPTED TO OBTAIN A PHOTOGRAPH, BUT THE DRILL BIT HAD ALREADY BEEN DISPOSED OF BY STAFF. THERE WAS NO IMPACTS TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.