TRINITY

Description of Event or Problem

DURING TOTAL HIP PROCEDURE. AS THE SURGEON WAS IMPLANTING CUP THE SCREW IN THE CUP IMPACTOR POPPED OFF. NOT ALLOWING THE SURGEON TO REMOVE THE CUP. DELAYING CASE SINCE CUP WAS STUCK ON HANDLE.

Additional Manufacturer Narrative

(B)(4) INITIAL REPORT. THE REPORTER HAS CONFIRMED THE DEVICE IS AVAILABLE FOR RETURN. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED, AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE REPORTING ENTITIES REPRESENTATIVE OR DISTRIBUTER CAUSED OR CONTRIBUTED TO THIS EVENT.

Description of Event or Problem

DURING TOTAL HIP PROCEDURE. AS THE SURGEON WAS IMPLANTING CUP THE SCREW IN THE CUP IMPACTOR POPPED OFF . NOT ALLOWING THE SURGEON TO REMOVE THE CUP. DELAYING CASE SINCE CUP WAS STUCK ON HANDLE.

Additional Manufacturer Narrative

(B)(4) FINAL REPORT ADDITIONAL INFORMATION INCLUDING 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 SURGERY WAS DELAYED DUE TO THE DEVICES GETTING STUCK TOGETHER. . THE DEVICES WERE RETURNED, WHERE THE FAILURE WAS CONFIRMED: THESE DEVICES CANNOT BE SEPERATED. 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. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE REPORTING ENTITIES REPRESENTITIVE OR DISTRUBUTERCAUSED OR CONTRIBUTED TO THIS EVENT.