TRINITY

Description of Event or Problem

DURING SURGERY THE TRINITY STD INTRODUCER / IMPACTOR HANDLE WOULD NOT RELEASE FROM THE ACETABULAR CUP. SURGERY WAS EXTENDED UNDER 30 MINUTES.

Additional Manufacturer Narrative

(B)(4) INITIAL REPORT. ADDITIONAL INFORMATION INCLUDING THE PART NO. AND LOT CODE OF THE TRINITY ACETABULAR SHELL THAT THE HANDLE GOT STUCK TO, CONFIRMATION ON WHETHER THE HANDLE EVENTUALLY DETACHED FROM THE SHELL OR WAS THE IMPACTED SHELL REMOVED AND ALTERNATIVE LOCATED AND USED AND CONFIRMATION ON THE QUANTITY OF AFFECTED DEVICES 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 HANDLE HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. UPON RECEIPT OF THE PART NO. AND LOT CODE OF THE ASSOCIATED TRINITY ACETABULAR SHELL, THESE MANUFACTURING RECORDS WILL ALSO BE IDENTIFIED AND REVIEWED. 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 STD INTRODUCER / IMPACTOR HANDLE WOULD NOT RELEASE FROM THE ACETABULAR CUP. SURGERY WAS EXTENDED UNDER 30 MINUTES.

Additional Manufacturer Narrative

(B)(4) FINAL REPORT: ADDITIONAL INFORMATION INCLUDING THE PART NO. AND LOT CODE OF THE TRINITY ACETABULAR SHELL THAT THE HANDLE GOT STUCK TO, CONFIRMATION ON WHETHER THE HANDLE EVENTUALLY DETACHED FROM THE SHELL OR WAS THE IMPACTED SHELL REMOVED AND ALTERNATIVE LOCATED AND USED AND CONFIRMATION ON THE QUANTITY OF AFFECTED DEVICES WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER, THIS INFORMATION WAS NOT PROVIDED AND THUS THE SCOPE OF THE INVESTIGATION WAS LIMITED. THE REPORTED DEVICES HAVE NOT BEEN RETURNED FOR EXAMINATION. THE APPROPRIATE DEVICE DETAILS FOR THE 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. BASED ON THE AVAILABLE INFORMATION, NO FURTHER INVESTIGATION CAN BE CONDUCTED. THIS REPORT CANNOT BE CONFIRMED AND THE ROOT CAUSE CANNOT BE DETERMINED. THEREFORE, THIS CASE IS NOW CONSIDERED CLOSED, HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED THEN THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION 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.