ROTATING SURGICAL PUNCHES 4.0MM 6BOX ST

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 OUTSIDE OF THE PACKAGING AND SHOWED SIGNS OF ATTEMPTED USE INCLUDING DEBRIS ON THE TIP CUTTING SURFACES. THE PLUNGERS FOR BOTH PUNCHES WERE PULLED BACK AND THE CUTTING TIP FULLY RETRACTED INTO THE PUNCH BODY ON BOTH PUNCHES. THE CUTTING ACTION APPEARS TO BE WORKING AS IT SHOULD ON BOTH PUNCHES. THE CAPS FOR THE PUNCHES WERE FULLY SEATED WHEN RECEIVED. THE CAPS WERE REMOVED AND RE-INSTALLED AND LOCKED IN PLACE AS DESIGNED. THE COMPLAINT IS UNABLE TO BE CONFIRMED. THE SHARPNESS OF THE BLADES IS UNABLE TO BE TESTED DUE TO ATTEMPTED PRODUCT USE. 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. 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.

Description of Event or Problem

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

Description of Event or Problem

IT WAS REPORTED THAT THE SURGICAL PUNCHES WERE NOT SHARP ENOUGH WHEN USED ON A 28 MM ARTIFICIAL BLOOD VESSEL. THERE WAS NO HARM OR DELAY IN PROCEDURE. ANOTHER PUNCH WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

ZIMMER BIOMET COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS. ITEM# 080-401, LOT# 09419, ROTATING SURGICAL PUNCHES 4.0MM 6BOX ST. 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.