ROTATING SURGICAL PUNCH

Additional Manufacturer Narrative

ZIMMER BIOMET COMPLAINT (B)(4) 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.

Description of Event or Problem

IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS FOUND INSIDE THE PACKAGING DURING A PRODUCT INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

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 PICTURE. THE PICTURE SHOWS A SINGLE PIECE OF DEBRIS STUCK TO THE PRODUCT PACKAGING. FROM THE PICTURE A DETERMINATION CANNOT BE MADE WHETHER THE DEBRIS IS ON THE INSIDE OR THE OUTSIDE OF THE STERILE PACKAGING. AS NO PRODUCT WAS RETURNED MEASUREMENTS CANNOT BE CONDUCTED TO CONFIRM IF THE DEBRIS IS CONFORMING OR NOT AS IT COULD NOT BE DETERMINED IF THE PHOTO IS TO SCALE. PER PROCEDURE, THE DEBRIS IS TO BE MEASURED WITH A CALIBRATED TAPPI STANDARD T564 (SIZE ESTIMATION CHART) IF NEEDED TO ESTIMATE THE SIZE OF THE IDENTIFIED PARTICLES. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING ISSUE. DEBRIS LIKELY RESULTED FROM THE MANUFACTURING PROCESS AS EVENT WAS IDENTIFIED ON UNOPENED PRODUCT BUT, OUR EVALUATION IS LIMITED AS NO PRODUCT WAS RETURNED AND PRODUCT ACCEPTABILITY FOR DEBRIS SIZE AND ACCEPTABILITY TO ESTABLISHED INSPECTION CRITERIA CANNOT BE DETERMINED FROM SUPPLIED PHOTOS. 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 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, G3, G6, H2, H3, H4, H6 AND H10.