A&E MEDICAL / ROTATING SURGICAL PUNCHES

Description of Event or Problem

IT WAS REPORTED THAT A ROTATING SURGICAL PUNCH WAS USED BY THE SURGEON TO MAKE A HOLE FOR PROXIMAL ANASTOMOSIS DURING A CORONARY ARTERY BYPASS PROCEDURE. AFTER USE OF THE PUNCH, THE SURGEON DISCOVERED A SMALL PIECE OF PLASTIC SITTING ON TOP OF THE AORTA. THE SMALL PIECE OF PLASTIC DISLODGED FROM THE PUNCH AND WAS NOTICED BY THE SURGEON BEFORE IT FELL INTO THE HOLE MADE IN THE AORTA BY THE PUNCH. THE SURGEON GAVE THE SMALL PIECE OF PLASTIC TO THE SCRUB NURSE TO KEEP ON THE BACK TABLE AND QUARANTINE. THERE WAS NO APPARENT HARM TO THE PATIENT.

Additional Manufacturer Narrative

ZIMMER BIOMET COMPLAINT (B)(4). G2: FOREIGN SOURCE: 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

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

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, G3, G6, H2, H3, H6, AND H10. THE CORRECTION IS IN B3.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) 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 WHICH 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.