TRINITY

Additional Manufacturer Narrative

(B)(4) FINAL REPORT IT HAS BEEN REPORTED THAT THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS EVENT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN 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. THE DEVICES WERE RETURNED TO CORIN AND EXAMINED. THE DEVICES WERE ABLE TO BE REMOVED BY HAND WITH EXCESSIVE FORCE AND DAMAGE WAS OBSERVED ON THE THREADS. THIS FAILURE HAS BEEN REPORTED TO CORIN PREVIOUSLY AND A NEW DESIGN IS BEING IMPLEMENTED TO THE TRINITY HANDLE. THEREFORE, THIS CASE IS NOW CONSIDERED CLOSED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE 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.

Additional Manufacturer Narrative

(B)(4). INITIAL REPORT. IT HAS BEEN REPORTED THAT THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS EVENT. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. THE REPORTED DEVICES ARE BEING RETURNED TO CORIN AND WILL BE EXAMINED. DETAILS OF THE 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 ADVERSE 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

2 TRINITY STD INTRODUCER / IMPACTOR HANDLES: GOT STUCK WITH THE TRINITY CUPS.