A&E MEDICAL / ROTATING SURGICAL PUNCHES

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.

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: UDI: (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.

Description of Event or Problem

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