RSP 4.0MM 6BOX ST
Received Jun 6, 2025 · Event occurred May 16, 2025
Report 0002242056-2025-00031 · MDR key 22158921
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
NA · Unknown
- Unspecified Tissue Injury
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN SOURCE: ITALY. 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. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1 ¿ ADVERSE EVENT WAS INCORRECTLY CHECKED IN THE INITIAL REPORT B2- OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) WAS INCORRECTLY CHECKED IN THE INITIAL REPORT H1: SERIOUS INJURY WAS INCORRECTED CHECKED IN THE INITIAL REPORT THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H4, H6, H11 NO PRODUCT WAS RETURNED. THE CUSTOMER PROVIDED PICTURE ONLY SHOWS THE PRODUCT PACKAGING AND NOT THE PRODUCT ITSELF. THE COMPLAINT IS UNABLE TO BE CONFIRMED FROM THE PROVIDED INFORMATION. THE DEVICE HISTORY RECORDS FOR [080-401, 25004] WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH THE FOLLOWING RELATED ANOMALIES/DEVIATIONS IDENTIFIED: 11 OUT OF 3000 PARTS ON THIS LOT WERE SCRAPPED FOR FAILING THE CUTTING FUNCTIONAL TEST. SCRAP RATES ARE TRACKED AND REVIEWED MONTHLY TO IDENTIFY TRENDS, SPIKES, OR DATA INACCURACIES THAT MAY LEAD TO FURTHER INVESTIGATION OR QUALITY ACTION ITEMS. THE RATE FOR ROTATING SURGICAL PUNCHES BEING SCRAPPED DUE TO FAILING CUTTING TESTS HAS NOT LED TO SUCH INVESTIGATIONS OR ACTIONS. 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 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.