TRINITY

Additional Manufacturer Narrative

(B)(4). FINAL REPORT THE REPORTED DEVICES WERE RETURNED AND EXAMINED. IT WAS CONFIRMED THAT PART OF THE THREAD OF THE HANDLE HAD BROKEN OFF IN THE APPICAL OCCLUDER HOLE OF THE TRINITY PLUS SHELL. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. 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 FOLLOWING THE FEEDBACK FROM THE FIELD, CORIN HAS IMPLEMENTED A NEW DESIGN FOR THE TRINITY INTRODUCER HANDLE. THE DEVICE REPORTED IN THIS EVENT WAS MANUFACTURED PRIOR TO THIS CHANGE AND THUS 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.

Description of Event or Problem

THE THREAD OF A TRINITY INTRODUCER HANDLE BROKE OFF IN THE TRINITY PLUS SHELL. THE SURGEON HAD TO REMOVE THE IMPACTED SHELL, RE-REAM AND IMPLANT A LARGER SIZE SHELL.

Description of Event or Problem

THE THREAD OF A TRINITY INTRODUCER HANDLE BROKE OFF IN THE TRINITY PLUS SHELL. THE SURGEON HAD TO REMOVE THE IMPACTED SHELL, RE-REAM AND IMPLANT A LARGER SIZE SHELL.

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. THE REPORTED DEVICES ARE BEING RETURNED AND WILL BE EXAMINED. DETAILS OF THIS 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 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.