RSP 3.5MM 6BOX ST

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H4, H6, H10, H11 NO PRODUCT WAS RETURNED. FOR 080-351 LOT 24993 THERE APPEARS TO BE A REDDISH DEBRIS INSIDE OF THE PACKAGE. IT CANNOT BE DETERMINED WHAT THE DEBRIS IS. NO HAIR IS VISIBLE IN THE PICTURE. THE MOST LIKELY ROOT CAUSE IS THE HAIR/ DEBRIS ENTERING THE PACKAGE DURING THE PACKAGING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS NON-CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS THE OPERATOR NOT FOLLOWING THE PROVIDED WORK INSTRUCTIONS DURING MANUFACTURING. THE REPORTED EVENT IS CONFIRMED, BASED ON PROVIDED PHOTOS. 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 EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

ZIMMER BIOMET (B)(4). G2: FOREIGN SOURCE: 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.

Description of Event or Problem

IT WAS REPORTED DURING THE INCOMING INSPECTION AT A WAREHOUSE, A TEAM MEMBER FOUND A A FOREIGN SUBSTANCE IN THE PACKAGE.