TRINITY

Additional Manufacturer Narrative

PER (B)(4) FINAL REPORT. 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 HANDLE HAS BEEN RELEASED AND THUS THIS CASE IS CONSIDERED CLOSED. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTER CAUSED OR CONTRIBUTED TO THIS EVENT 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

Description of Event or Problem

TRINITY STD INTRODUCER / IMPACTOR HANDLE: BECAME STUCK WITH THE SHELL INTRA-OPERATIVELY.

Additional Manufacturer Narrative

PER (B)(4) INITIAL REPORT. THE REPORTER HAS CONFIRMED THE DEVICE IS AVAILABLE FOR RETURN. 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 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.

Description of Event or Problem

TRINITY STD INTRODUCER / IMPACTOR HANDLE: BECAME STUCK WITH THE SHELL INTRA-OPERATIVELY.