TRINITY
Received Nov 19, 2024 · Event occurred Oct 24, 2024
Report 9614209-2024-00398 · MDR key 20722255
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
Description of Event or Problem
TRINITY STD INTRODUCER/IMPACTOR HANDLE COULD NOT BE DISENGAGED FROM THE TRINITY-I PLUS CUP INTRA-OPERATIVELY. AN ALTERNATIVE HANDLE AND CUP WERE LOCATED AND USED WITH NO ISSUE.
Additional Manufacturer Narrative
PER (B)(4). FINAL REPORT. THE REPORTED HANDLE AND CUP WERE RETURNED TO CORIN AND WERE EXAMINED. IT WAS CONFIRMED THAT THE TWO PARTS COULD NOT BE SEPERATED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. IT IS POSSIBLE THAT THERE MAY HAVE BEEN DAMAGED TO THE THREAD PRIOR TO ENGAGING WITH THE CUP WHICH WENT UN-IDENTIFIED, RESULTING IN THE TWO DEVICES COLD-WELDING AND NOT BEING ABLE TO BE DISENGAGED. CORIN HAS IMPLEMENTED A DESIGN CHANGE TO THE TRINITY HANDLE AND THE HANDLE REPORTED IN THIS EVENT WAS MANUFACTURED PRIOR TO THIS DESIGN CHANGE. 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
TRINITY STD INTRODUCER/IMPACTOR HANDLE: STUCK TO THE IMPLANT FOLLOWING IMPACTION.
Additional Manufacturer Narrative
(B)(4) INITIAL REPORT. PLEASE NOTE: THE SYSTEM WOULD NOT ALLOW THIS INITIAL REPORT TO BE PACKAGED WITHOUT AN OPTION FOR B, C AND D SELECTED IN SECTION H. AS THIS IS AN INITIAL REPORT THE INVESTIGATION FINDINGS ARE NOT YET KNOWN. THESE WILL BE UPDATED IN THE FINAL REPORT. THE REPORTED HANDLE AND CUP ARE BEING RETURNED TO CORIN AND WILL BE EXAMINED. DETAILS OF THIS EXAMINATION WILL BE PROVDIED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL 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.