RSP 2.7MM 6BOX ST

Description of Event or Problem

NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED. A VISUAL INSPECTION WAS CONDUCTED ON THE CUSTOMER PROVIDED PICTURES. FOR 080-271 LOT 15537 INSPECTION OF PROVIDED PICTURES SHOW THAT THERE IS A HAIR INSIDE OF THE INTERNAL PACKAGING. PER INSPECTION CRITERIA, PRODUCT IS INSPECTED FOR NO EXCESS PARENT OR FOREIGN PARTICLES. INSPECTION OF THE PACKAGING PICTURES SHOWED A SINGLE HAIR INSIDE OF THE PRODUCT PACKAGING. THE COMPLAINT IS CONFIRMED. 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.

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 THE WAREHOUSE, A TEAM MEMBER FOUND A HAIR-LIKE SUBSTANCE IN PACKAGE.