TRINITY

Additional Manufacturer Narrative

(B)(4) INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING TIME CONFIRMATION OF THE SURGICAL DELAY, WHETHER THE THREAD OF THE HANDLE CHECKED PRIOR TO USE, IF SO - WAS ANY DAMAGE OBSERVED, DID THE SURGEON HAVE TO RE-REAM AND IMPLANT A LARGER SIZE SHELL AND OTHER THAN THE SURGICAL DELAY WAS THERE ANY IMPACT FOR THE PATIENT, 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. 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 GOT STUCK WITH THE TRINITY SHELL AFTER IMPACTION (SURGEON SWITCHED TO A COMPETITOR PRODUCT).

Description of Event or Problem

TRINITY STD INTRODUCER / IMPACTOR HANDLE GOT STUCK WITH THE TRINITY SHELL AFTER IMPACTION (SURGEON SWITCHED TO A COMPETITOR PRODUCT).

Additional Manufacturer Narrative

(B)(4) FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING TIME CONFIRMATION OF THE SURGICAL DELAY, WHETHER THE THREAD OF THE HANDLE CHECKED PRIOR TO USE, IF SO - WAS ANY DAMAGE OBSERVED, DID THE SURGEON HAVE TO RE-REAM AND IMPLANT A LARGER SIZE SHELL AND OTHER THAN THE SURGICAL DELAY WAS THERE ANY IMPACT FOR THE PATIENT, 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 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. REVIEW OF THE RETURNED DEVICES SHOWED SIGNS OF WEAR ON THE HANDLE AND THREAD DAMAGE TO THE HANDLE AND SHELL INDICATING THAT THE DEVICES BECAME CROSS-THREADED DURING USE, HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE CROSS-THREADING COULD NOT BE DETERMINED. NO FURTHER INVESTIGATION CAN BE CONDUCTED AND THIS CASE IS NOW CONSIDERED CLOSED. 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.