TRINITY
Received Nov 20, 2024 · Event occurred Oct 28, 2024
Report 9614209-2024-00404 · MDR key 20733990
Device
Product problems
- Mechanical Jam
- Insufficient Device Problem Information
- Mechanical Jam
- 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 CROSS-THREADED WITH THE CUP. ALTERNATIVE HANDLE AND CUP HAD TO BE LOCATED AND USED.
Additional Manufacturer Narrative
PER - (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. RETURN OF THE DEVICE AND THE PART NO. / LOT CODE OF THE TRINITY CUP HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED 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. 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 THIS DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.
Description of Event or Problem
TRINITY STD INTRODUCER / IMPACTOR HANDLE CROSS-THREADED WITH THE CUP. ALTERNATIVE HANDLE AND CUP HAD TO BE LOCATED AND USED.
Additional Manufacturer Narrative
PER -8366 FINAL REPORT. RETURN OF THE DEVICE AND THE PART NO. / LOT CODE OF THE TRINITY CUP WAS REQUESTED AND PROVIDED. THE REPORTED DEVICES WERE RETURNED AND THE FAILURE WAS CONFIRMED. 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. THIS FAILURE HAS BEEN REPORTED TO CORIN PREVIOUSLY AND AS A RESULT OF FEEDBACK, A NEW DESIGN HAS BEEN RELEASED FOR THE TRINITY HANDLE, 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 THIS DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.