RSP 3.5MM 6BOX ST

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 IS REPORTED THAT THERE WAS FOREIGN DEBRIS IN THE STERILIZATION PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A VISUAL INSPECTION WAS CONDUCTED ON THE TWO RETURNED PUNCHES. THE PUNCHES WERE RETURNED OPENED AND NO LONGER INSIDE OF THE PACKAGING. THE PRODUCT WAS RETURNED IN A BAG NOT ASSOCIATED WITH THE PRODUCT. INSIDE OF THESE BAGS, SMALL PIECES OF BLACK DEBRIS COULD BE SEEN AND CIRCLED. AS THE PRODUCT HAS BEEN OPENED AND RETURNED IN BAGS NOT ORIGINALLY ASSOCIATED WITH THE PRODUCT THE COMPLAINT IS UNABLE TO BE CONFIRMED AS IT CANNOT BE DETERMINED WHEN AND WHERE THE DEBRIS CAME FROM. THE DEBRIS WAS INSPECTED WITH A MICROSCOPE AND DETERMINED IT IS NOT AN INSECT AND COULD NOT DETERMINE WHAT THE DEBRIS IS. MANUFACTURING PROCESS WAS REVIEWED AND CONFIRMED THAT THIS TYPE OF DEBRIS IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. AS THE PRODUCT HAS BEEN OPENED AND RETURNED IN BAGS NOT ORIGINALLY ASSOCIATED WITH THE PRODUCT IT CANNOT BE DETERMINED WHEN AND WHERE THE DEBRIS CAME FROM. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, D4, D9, G3, G6, H2, H3, H4, H6, H10 AND H11.

Description of Event or Problem

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