TRINITY

Description of Event or Problem

TRINITY STD INTRODUCER / IMPACTOR HANDLE WOULD NOT DISENGAGE FROM THE TRINITY SHELL (ALTERNATIVES LOCATED AND USED).

Additional Manufacturer Narrative

(B)(4) INITIAL REPORT. PLEASE NOTE: THE SYSTEM WOULD NOT ALLOW THIS INITIAL REPORT TO BE PACKAGED WITHOUT AN OPTION FOR B, C AND D SELECTED IN SECTION H. AS THIS IS AN INITIAL REPORT THE INVESTIGATION FINDINGS ARE NOT YET KNOWN. THESE WILL BE UPDATED IN THE FINAL REPORT. ADDITIONAL INFORMATION INCLUDING A PHOTOGRAPH OF THE DEVICES AND WHETHER THE SURGEON RE-REAMED AND IMPLANTED A LARGER THAN PLANNED SIZE CUP 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.

Description of Event or Problem

TRINITY STD INTRODUCER / IMPACTOR HANDLE WOULD NOT DISENGAGE FROM THE TRINITY SHELL (ALTERNATIVES LOCATED AND USED).

Additional Manufacturer Narrative

(B)(4). FINAL REPORT ADDITIONAL INFORMATION INCLUDING A PHOTOGRAPH OF THE DEVICES AND WHETHER THE SURGEON RE-REAMED AND IMPLANTED A LARGER THAN PLANNED SIZE CUP WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT AND WERE PROVIDED. IT WAS CONFIRMED THAT THE SAME SIZE CUP WAS IMPLANTED AND THE SURGEON DID NOT NEED TO RE-REAM TO A LARGER SIZE. IT WAS CONFIRMED THAT THE DEVICES WERE SEPERATED FOLLOWING RE-PROCESSING AND PHOTOS WERE PROVIDED TO CONFIRM THIS. DAMAGE COULD BE SEEN ON THE THREADS OF THE HANDLE AND 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 DESIGN CHANGE HAS BEEN IMPLEMENTED TO THE TRINITY HANDLE. THE DEVICE RELATED TO THIS REPORT WAS MANUFACTURED PRIOR TO THE CHANGE 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 CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.