TRINITY

Description of Event or Problem

DURING SURGERY, THE TRINITY HANDLE WAS IMPACTED AND SUBSEQUENTLY, THE THREAD OF THE INTRODUCER HANDLE BROKE OFF INSIDE THE PATIENT. THIS WAS RETRIEVED AND THERE WAS NO DELAY IN SURGERY AND NO REPORTED PATIENT IMPACT.

Additional Manufacturer Narrative

(B)(4). INITIAL REPORT ADDITIONAL INFORMATION, INCLUDING COULD THE THREAD HAVE BEEN DAMAGED PRIOR TO IMPACTION OF THE LINER (WHEN IMPACTING THE TRIAL CUP OR DEFINITIVE ACETABULAR CUP), WAS THE TRINITY HANDLE THREADED INTO THE LINER IMPACTOR HEAD WHEN IMPACTING THE LINER, WAS THE HANDLE WAS SCREWED INTO THE LINER IMPACTOR HEAD WHILST IMPACTING THE LINER, THIS FAILURE SHOULD ONLY HAVE BEEN IDENTIFIED WHEN REMOVING THE LINER IMPACTOR HEAD FROM THE HANDLE ONCE THE LINER WAS ENGAGED - IS THIS WHAT HAPPENED AND WAS THERE ANY DAMAGE TO THE LINER IMPACTOR HEAD 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 HAS BEEN REQUESTED AND ONCE PROVIDED 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.

Additional Manufacturer Narrative

(B)(4) FINAL REPORT THE REPORTER CONFIRMED THAT THE DAMAGE TO THE IMPACTOR WAS OBSERVED AFTER THE CUP IMPLANT HAD BEEN IMPACTED. THE DEVICE DETAILS WERE PROVIDED AND MANUFACTURE RECORDS REVIEWED. REVIEW OF THESE RECORDS REVEALED NO PRODUCT OR NON-CONFORMITY THAT WOULD HAVE CAUSED THE REPORTED EVENT. THE DEVICE WAS FOUND TO HAVE BEEN IN USE FOR 6 YEARS AT THE TIME OF FAILURE, AND THE ROOT CAUSE OF THE EVENT DETERMINED TO BE NORMAL WEAR AND TEAR. 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

DURING SURGERY, THE TRINITY HANDLE WAS IMPACTED AND SUBSEQUENTLY, THE THREAD OF THE INTRODUCER HANDLE BROKE OFF INSIDE THE PATIENT. THIS WAS RETRIEVED AND THERE WAS NO DELAY IN SURGERY AND NO REPORTED PATIENT IMPACT.