TRINITY
Received Sep 10, 2024 · Event occurred Aug 29, 2024
Report 9614209-2024-00376 · MDR key 20178199
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PER -(B)(4) FINAL REPORT. THE REPORTED DEVICES WERE RETURNED AND EXAMINED. THE REPORTED FAILURE WAS CONFIRMED. IT WAS STATED THAT THE DEVICE LOT CODE OF THE HANDLE WAS UNREADABLE, THIS WAS CHECKED UPON RECEIPT OF THE DEVICE AND THE LOT CODE IDENTIFIED. THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED. IT WAS FOUND THAT ALL FINISHED PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. THIS FAILURE HAS BEEN REPORTED PREVIOUSLY AND AS A RESULT, A DESIGN CHANGE HAS BEEN IMPLEMENTED TO THE TRINITY HANDLE. THEREFORE, THIS CASE IS NOW CONSIDERED CLOSED. 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
DURING SURGERY, THE TRINITY STD INTRODUCER / IMPACTOR HANDLE COULD NOT DISENGAGE FROM THE TRINITY SHELL POST IMPACTION. THE SHELL WAS REMOVED AND AN ALTERNATIVE WAS LOCATED AND IMPLANTED WITH NO ISSUE.
Additional Manufacturer Narrative
PER -7691 INITIAL REPORT. THE REPORTED DEVICES ARE BEING RETURNED AND WILL BE EXAMINED. IT WAS STATED THAT THE DEVICE LOT CODE OF THE HANDLE WAS UNREADABLE, THIS WILL BE CHECKED UPON RECEIPT OF THE DEVICE. THE APPROPRIATE DEVICE DETAILS WILL BE CONFIRMED WHEN THE PARTS ARE RETURNED TO CORIN UK. THE RELEVANT DEVICE MANUFACTURING RECORDS WILL THEN BE IDENTIFIED AND REVIEWED. 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
DURING SURGERY, THE TRINITY STD INTRODUCER / IMPACTOR HANDLE COULD NOT DISENGAGE FROM THE TRINITY SHELL POST IMPACTION. THE SHELL WAS REMOVED AND AN ALTERNATIVE WAS LOCATED AND IMPLANTED WITH NO ISSUE.