TRINITY

Additional Manufacturer Narrative

PER (B)(4) FINAL REPORT. ADDITIONAL INFORMATION INCLUDING PHOTOGRAPHS OF THE HANDLES, WHETHER THE THREADS OF THE HANDLES WERE EXAMINED / CHECKED FOR ANY WEAR OR DAMAGED PRIOR TO USE IN SURGERY, WHETHER THESE ISSUES OCCUR IN ONE SURGERY OR TWO DIFFERENT SURGERIES, PART NUMBERS AND LOT CODES OF THE ASSOCIATED TRINITY SHELLS, WHETHER THE SHELLS WERE IMPACTED IN THE PATIENT'S ACETABULUM WHEN THE SHELLS AND HANDLES BECAME STUCK, WHETHER THE IMPACTED SHELLS WERE REMOVED FROM THE ACETABULUM AND WHETHER THE SURGEON HAD TO RE-REAM TO A LARGER SIZE OR WAS THE PLANNED SIZE SHELL FINALLY IMPLANTED, WAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTGATION OF THIS EVENT,. THE REPORTER CONFIRMED THAT THE SURGEON HAS DIFFICULTY REMOVING THE PERMANENT CUP AND REPOSITIONING IT BUT WAS EVENTUALLY ABLE TO IMPLANT THE INTENDED CUP. 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. 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 CONSITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

Description of Event or Problem

DURING A TRINITY SURGERY 2 TRINITY STD INTRODUCER/IMPACTOR HANDLES COULD NOT UNSCREW FROM THE DEFINITIVE CUPS. THE IMPACTED CUPS HAD TO BE REMOVED AND ALTERNATIVE INSTRUMENTS/IMPLANTS LOCATED AND USED. THE REPORTER HAS STATED THAT THERE MAY HAVE BEEN WEAR TO THE THREADS OF THE HANDLES.

Description of Event or Problem

DURING A TRINITY SURGERY 2 TRINITY STD INTRODUCER / IMPACTOR HANDLES COULD NOT UNSCREW FROM THE DEFINITIVE CUPS. THE IMPACTED CUPS HAD TO BE REMOVED AND ALTERNATIVE INSTRUMENTS / IMPLANTS LOCATED AND USED. THE REPORTER HAS STATED THAT THERE MAY HAVE BEEN WEAR TO THE THREADS OF THE HANDLES.

Additional Manufacturer Narrative

PER COMP - 245 INITIAL REPORT ADDITIONAL INFORMATION INCLUDING PHOTOGRAPHS OF THE HANDLES, WHETHER THE THREADS OF THE HANDLES WERE EXAMINED / CHECKED FOR ANY WEAR OR DAMAGED PRIOR TO USE IN SURGERY, WHETHER THESE ISSUES OCCUR IN ONE SURGERY OR TWO DIFFERENT SURGERIES, PART NUMBERS AND LOT CODES OF THE ASSOCIATED TRINITY SHELLS, WHETHER THE SHELLS WERE IMPACTED IN THE PATIENT'S ACETABULUM WHEN THE SHELLS AND HANDLES BECAME STUCK, WHETHER THE IMPACTED SHELLS WERE REMOVED FROM THE ACETABULUM AND WHETHER THE SURGEON HAD TO RE-REAM TO A LARGER SIZE OR WAS THE PLANNED SIZE SHELL FINALLY IMPLANTED, 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. 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 THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.