MILLER BONE CEMENT INJECTOR

Description of Event or Problem

IT WAS REPORTED THAT WHEN THE PRODUCTS WERE RECEIVED BY THE DISTRIBUTOR, THEY WERE FOUND TO HAVE DAMAGED PACKAGING. THE OUTER CAVITY WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN ¿ JAPAN. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H6; H10 -VISUAL EVALUATION OF (2) OF THE CARTRIDGE KITS FOUND THE OUTER CAVITY IS CRACKED. AMONGST THE 2 SAMPLES (1) HAD AN INNER CAVITY THAT WAS CRACKED AND (1) HAD AN INNER CAVITY THAT WAS WARPED AND DEFORMED WITH NO CRACKS. STERILITY IS CONSIDERED BREACHED. -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. -THE CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONSIDERED CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO TRANSIT DAMAGE. -THIS COMPLAINT WAS CONFIRMED BY EVALUATION OF THE PROVIDED PHOTOS AND RETURNED PRODUCT. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.