ROTATING SURGICAL PUNCH 4.0MM TAPERED TIP

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. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PRODUCT. THE PRODUCT WAS RECEIVED WITH INTERNAL PACKAGING STILL SEALED. FURTHER INSPECTION SHOWS THAT THERE IS A HAIR INSIDE OF THE INTERNAL PACKAGING. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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. 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 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 HAIR-LIKE SUBSTANCE WAS IDENTIFIED INSIDE THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.