TRINITY
Received Nov 3, 2025 · Event occurred Oct 21, 2025
Report 9614209-2025-00597 · MDR key 23449954
Device
Product problems
- Mechanical Jam
- Mechanical Jam
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
TRINITY STD INTRODUCER / IMPACTOR HANDLE: STUCK TO TRINITY SHELL INTRA-OPERATIVELY.
Additional Manufacturer Narrative
PER (B)(4) FINAL REPORT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACATURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. REVIEW OF THESE RECORDS REVEALED NO PRODUCT NON-CONFORMITY OR DEVIATION FROM PROCESS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED DEVICES WERE RETURNED AND EXAMINED. THE THREADS OF BOTH THE HANDLE AND SHELL WERE EXAMINED AND SOME SLIGHT BURRING WAS OBSERVED ON THE THREAD OF THE HANDLE BUT NO DAMAGE WAS SEEN ON THE THREAD OF THE SHELL. IT IS POSSIBLE THAT THE WEAR SEEN ON THE THREAD OF THE HANDLE LED TO THE EVENT EXPERIENCED BY THE REPORTER, HOWEVER, THE FAILURE COULD NOT BE REPLICATED WITH A FUNCTIONAL TEST AT CORIN UK. POSSIBLE TO BE WEAR AND TEAR FROM THE HANDLE THAT LED TO THE EVENT, THUS THIS CASE IS NOW CONSIDERED CLOSED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.
Description of Event or Problem
TRINITY STD INTRODUCER/IMPACTOR HANDLE: STUCK TO TRINITY SHELL INTRA-OPERATIVELY.
Additional Manufacturer Narrative
PER (B)(4) INITIAL REPORT. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. THE REPORTED DEVICES ARE BEING RETURNED FOR EXAMINATION AND DETAILS OF THIS EXAMINATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.