RINGLOC+

Additional Manufacturer Narrative

(B)(4). H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) - DRILL THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE REASON WHY IT WILL NOT BE RETURNED WAS NOT SPECIFIED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE DRILL BIT BROKE OFF INSIDE THE PATIENT DURING USE.THERE WAS PATIENT INVOLVEMENT DUE TO THE BROKEN DRILL BIT FRAGMENT REQUIRING RETRIEVAL; HOWEVER, THERE WERE NO REPORTED HEALTH CONSEQUENCES OR PATIENT IMPACT.ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.