TRINITY

Additional Manufacturer Narrative

(B)(4) FINAL REPORT. ADDITIONAL INFORMATION INCLUDING THE PART NO. AND LOT CODE OF THE ASSOCIATED TRINITY SHELL, WHETHER THE THREAD OF THE HANDLE EXAMINED PRIOR TO USE, WHETHER ANY DAMAGE TO THE THREADS WAS OBSERVED AND WHETHER THE SURGEON HAD TO RE-REAM TO A LARGER SIZE OR WAS AN ALTERNATIVE SHELL OF THE SAME SIZE LOCATED AND IMPLANTED WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER, NONE OF THIS INFORMATION WAS PROVIDED AND THUS THE SCOPE OF THE INVESTIGATION WAS LIMITED. THE APPROPRIATE DEVICE DETAILS FOR THE TRINITY 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. ONLY THE HAND GRIP SECTION OF THE INSTRUMENT WAS RETURNED AND THE ASSOCIATED CUP WAS NOT RETURNED. BASED ON THIS, THE REPORT CANNOT BE VERIFIED AND THUS THIS CASE IS CONSIDERED CLOSED. SHOULD ADDITIONAL INFORMATION BE PROVIDED THEN THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. 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: UNABLE TO REMOVE FROM THE TRINITY SHELL POST IMPACTION. SHELL REMOVED AND ALTERNATIVE LOCATED AND IMPLANTED.

Additional Manufacturer Narrative

(B)(4) INITIAL REPORT. ADDITIONAL INFORMATION INCLUDING THE PART NO. AND LOT CODE OF THE ASSOCIATED TRINITY SHELL, WHETHER THE THREAD OF THE HANDLE EXAMINED PRIOR TO USE, WHETHER ANY DAMAGE TO THE THREADS WAS OBSERVED AND WHETHER THE SURGEON HAD TO RE-REAM TO A LARGER SIZE OR WAS AN ALTERNATIVE SHELL OF THE SAME SIZE LOCATED AND 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 FOR THE TRINITY HANDLE HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORD WILL BE IDENTIFIED AND REVIEWED. UPON RECEIPT OF THE DEVICE DETAILS OF THE ASSOCIATED TRINITY SHELL, THESE MANUFACTURING RECORDS WILL ALSO 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: UNABLE TO REMOVE FROM THE TRINITY SHELL POST IMPACTION. SHELL REMOVED AND ALTERNATIVE LOCATED AND IMPLANTED.