RSP 4.0MM FLAT TIP 6BOX ST
Received Jun 18, 2025
Report 0002242056-2025-00032 · MDR key 22286614
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
NA · Unknown
- Unspecified Tissue Injury
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
(B)(4). G2 - REPORT SOURCE - FOREIGN: (B)(6). 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 DOES NOT CREATE A CIRCULAR HOLE. AS IT IS RETRACTED, IT TENDS TO FLAKE/FRAY THE AORTA. HOSPITAL REPORTED THAT THERE WAS NO DAMAGE TO THE PATIENT OR OTHER USER. THERE WAS NO SURGICAL DELAY FOUND. 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 AND/OR CORRECTED INFORMATION. UPDATED: B5, H2, H3, H4, H6 AND H11. REPORTED EVENT COULD NOT BE CONFIRMED AS DEVICE WAS NOT RETURNED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED 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
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.