TRINITY

Additional Manufacturer Narrative

PER - (B)(4) INITIAL REPORT. ADDITIONAL INFORMATION INCLUDING THE LOT CODE OF THE REPORTED HANDLE, PHOTOGRAPHS OF THE DEVICE AND THE PART NUMBER AND LOT CODE OF THE ASSOCIATED TRINITY SHELL HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. UPON RECEIPT OF THE APPROPRIATE DEVICE DETAILS, 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.

Description of Event or Problem

TRINITY STD INTRODUCER / IMPACTOR HANDLE CROSS-THREADED WITH THE TRINITY SHELL, CAUSING IT TO GET STUCK. THE SURGEON CHANGED TO ALTERNATE SIZE SHELL AND DIFFERENT HANDLE TO COMPLETE SURGERY.

Description of Event or Problem

TRINITY STD INTRODUCER / IMPACTOR HANDLE CROSS-THREADED WITH THE TRINITY SHELL, CAUSING IT TO GET STUCK. THE SURGEON CHANGED TO ALTERNATE SIZE SHELL AND DIFFERENT HANDLE TO COMPLETE SURGERY.

Additional Manufacturer Narrative

PER (B)(4) FINAL REPORT. ADDITIONAL INFORMATION INCLUDING THE LOT CODE OF THE REPORTED HANDLE, PHOTOGRAPHS OF THE DEVICE AND THE PART NUMBER AND LOT CODE OF THE ASSOCIATED TRINITY SHELL WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER, NOT ALL INFORMATION WAS PROVIDED AND THUS THE SCOPE OF THE INVESTIGATION WAS LIMITED. THE APPROPRIATE DEVICE DETAILS FOR THE REPORTED HANDLE WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORD HAS BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THIS RECORD CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. THE DEVICE DETAILS OF THE ASSOCIATED CUP WERE NOT PROVIDED, NOR WAS IT RETURNED FOR EXAMINATION AND THUS THE DEVICE MANUFACTURING RECORD CANNOT BE IDENTIFIED OR REVIEWED. THE REPORTED HANDLE WAS RETURNED AND THREAD DAMAGE WAS CONFIRMED. THE REPORTED FAILURE HAS BEEN REPORTED PREVIOUSLY AND A DESIGN CHANGE HAS BEEN IMPLEMENTED, 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.