TPRLC 133 T1 PPS HO 15X150MM 0MM T1

Additional Manufacturer Narrative

REPORTED EVENT WAS CONFIRMED WITH PRODUCT RETURN. VISUAL INSPECTION OF THE RETURNED PRODUCTS IDENTIFIED WHITE FOAM DEBRIS WITHIN THE SEALED BLISTERS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE LIKELY CONDITION OF THE PRODUCT WHEN LEAVING ZIMMER BIOMET WAS CONFORMING TO SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO TRANSIT DAMAGE. THIS DEVICE FALLS WITHIN THE SCOPE OF A CORRECTIVE ACTION, OF WHICH IS TO ASSESS ALL CURRENT STERILE BARRIER SYSTEMS USED TO PACKAGE PRODUCTS AT ZIMMER BIOMET BRIDGEND. AS PART OF THIS CAPA, THE POUCH IS BEING IMPROVED TO USE A STRONGER MATERIAL (NYLON), AND FOAM END CAPS ARE BEING ADDED. ALSO, THE ORIENTATION THE DEVICES ARE PACKED IN THE SHIPPER BOX IS MOVING FROM VERTICAL TO HORIZONTAL, AND THE THICKNESS OF THE SHIPPER BOX HAS BEEN INCREASED. 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 AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). FOREIGN COUNTRY: (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05654.

Description of Event or Problem

IT WAS REPORTED THAT AN INSPECTION TEAM MEMBER FOUND DEBRIS IN THE STERILE PACKAGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.