INSTRUMENT, HIP

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EVALUATION OF THE RETURNED PRODUCT FOUND FOREIGN DEBRIS IN THE SEALED STERILE PACKAGING. THIS COMPLAINT HAS BEEN CONFIRMED BY EVALUATION OF THE RETURNED PRODUCT. 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 NON-CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO PACKAGING OPERATOR NOT FOLLOWING THE WORK INSTRUCTIONS 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

THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

Description of Event or Problem

IT WAS REPORTED THAT DURING INCOMING INSPECTION, A TEAM MEMBER FOUND DEBRIS IN THE STERILE PACKAGING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). D1: FRONT LOADING CARTRIDGE KIT COMPATIBLE WITH VACUUM MIXING SYSTEM EACH INDIVIDUALLY STERILE PACKAGED G2: FOREIGN: JAPAN 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. H3 OTHER TEXT : DEVICE IN PROCESS TO RETURN.