4.0MM 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 IDENTIFIED IN THE PACKAGING DURING AN INCOMING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

Description of Event or Problem

NO FURTHER EVENT INFORMATION 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 ZOOMED IN VIEW OF THE PRODUCT PACKAGING. THE PICTURE SHOWS A SMALL CIRCULAR AREA OF DEBRIS AS WELL AS TWO OTHER PIECES OF DEBRIS. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING PACKAGING ISSUE. AN ISSUE EVALUATION WAS OPENED TO FURTHER EVALUATE THIS ISSUE. 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.