A&E MEDICAL / ROTATING SURGICAL PUNCHES

Description of Event or Problem

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

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE LOT INFORMATION COULD BE: D4 - LOT NUMBER - 06504. D4 - EXPIRY DATE - SEP 1, 2027. D4 ¿ (B)(4). H4 - MANUFACTURE DATE - SEP 16, 2022. OR THE LOT INFORMATION COULD BE: D4 - LOT NUMBER - 08539. D4 - EXPIRY DATE - DEC 1, 2027. D4- UDI-(B)(4). H4 - MANUFACTURE DATE - DEC 14, 2022. 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. 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.

Additional Manufacturer Narrative

ZIMMER BIOMET COMPLAINT (B)(4). D2: PRODUCT CODE: LRY. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE LOT INFORMATION COULD BE: D4 - LOT NUMBER - 06504. OR THE LOT INFORMATION COULD BE: D4 - LOT NUMBER - 08539. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THE PUNCH DOES NOT MAKE A CLEAN CUT. IT TORE A PART OF THE AORTA WHEN BEING DEPLOYED WHICH REQUIRED THE SURGEON TO PERFORM ADDITIONAL SUTURING OF THE HOLE. THERE WAS A SHORT DELAY TO REPAIR THE AORTIC PUNCHED HOLE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.