RSP 4.0MM 6BOX ST
Received Dec 8, 2025
Report 0002242056-2025-00044 · MDR key 23752631
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED DURING THE PROCEDURE, THE SURGEON USED THE DEVICE TO PREPARE THE PROXIMAL OPENING IN THE AORTA FOR THE GRAFT. HOWEVER, THE PUNCH FAILED TO MAKE A SUFFICIENT HOLE. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B5; D4; G3; H2; H4; H6; H11. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO PRODUCT NOT BEING RETURNED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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
IT WAS REPORTED DURING THE PROCEDURE, THE SURGEON USED THE DEVICE TO PREPARE THE PROXIMAL OPENING IN THE AORTA FOR THE GRAFT. HOWEVER, THE PUNCH FAILED TO MAKE A SUFFICIENT HOLE. THERE WAS NOT REPORTED PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN CANADA. THE DEVICE HAS NOT BEEN 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.