CARTRIDGE KIT

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: D5; G3; H2; H3; H4; H6. VISUAL EVALUATION OF THE PROVIDED PHOTO IDENTIFIED UNKNOWN DEBRIS. HOWEVER, AS THE PHOTO DOES NOT FULLY DEPICT THE ENTIRE PACKAGING CONSTRUCT AND THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION TO VERIFY IF THE PACKAGING HAS BEEN PREVIOUSLY OPENED, THE SOURCE OF THE DEBRIS CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN: JAPAN. 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 WHILE INSPECTING CIRCULATED ITEMS, IT WAS FOUND THAT THERE WAS DEBRIS IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, AND IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.