ROTATING SURGICAL PUNCH 4.0MM TAPERED TIP

Description of Event or Problem

IT WAS REPORTED THAT DURING A CABG PROCEDURE, THE SURGEON USED THE AORTIC PUNCH IN USUAL MANNER. AFTER USING THE PUNCH, THE SURGEON NOTICED THE ANASTOMOSIS WAS AN X SHAPE AND NOT A CIRCULAR HOLE. THE DEVICE WAS DISCARDED AND A LARGER PUNCH (4.8MM) WAS USED INSTEAD.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OF SUPPLIED PHOTO SHOWS AN IRREGULAR INCISION THAT IS NOT CIRCULAR. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

ZIMMER BIOMET COMPLAINT (B)(4). G2: FOREIGN - CANADA 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 THE PUNCH IS NOT CUTTING CORRECTLY. THE CUT WAS JAGGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.