TRINITY

Description of Event or Problem

TRINITY CUP GOT STUCK WITH THE TRINITY STD INTRODUCER / IMPACTOR HANDLE AND COULD NOT BE REMOVED INTRA-OP. AN ALTERNATIVE CUP AND HANDLE WERE LOCATED AND USED WITH NO ISSUES.

Additional Manufacturer Narrative

(B)(4) INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING THE LOT CODE OF THE TRINITY HANDLE, PHOTOGRAPHS OF THE DEVICES, DID THIS ISSUE OCCUR AFTER THE SHELL HAD BEEN IMPACTED IN THE ACETABULUM AND DID THE IMPACTED SHELL HAVE TO BE REMOVED FROM THE ACETABULUM, 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. UPON RECEIPT OF THE APPROPRIATE DEVICE DETAILS, THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. THE REPORTED DEVICES HAVE BEEN REQUESTED FOR RETURN, AND IF RECEIVED, WILL BE EXAMINED. 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.

Additional Manufacturer Narrative

(B)(4) FINAL REPORT ADDITIONAL INFORMATION, INCLUDING THE LOT CODE OF THE TRINITY HANDLE, PHOTOGRAPHS OF THE DEVICES, DID THIS ISSUE OCCUR AFTER THE SHELL HAD BEEN IMPACTED IN THE ACETABULUM AND DID THE IMPACTED SHELL HAVE TO BE REMOVED FROM THE ACETABULUM, HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT. IT WAS CONFIRMED THAT THE IMAPCTED SHELL HAD TO BE REMOVED FROM THE PATIENT'S ACETABULUM AND THE HANDLE / SHELL COULD NOT BE SEPERATED INTRA-OPERATIVELY. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL FINISHED PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. THE REPORTER STATED THAT IT IS SUSPECTED THAT THE SHELL WAS NOT FULLY THREADED ONTO THE HANDLE PRIOR TO IMPACTION, THUS LEADING TO THE DEVICES CROSS-THREADING AND NOT BEING ABLE TO BE SEPERATED. BASED ON THIS, THE ROOT CAUSE IS TRACED TO THE USER AND NO FURTHER INVESTIGATION IS REQUIRED. THIS CASE IS NOW CONSIDERED CLOSED. 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 CUP GOT STUCK WITH THE TRINITY STD INTRODUCER / IMPACTOR HANDLE AND COULD NOT BE REMOVED INTRA-OP. AN ALTERNATIVE CUP AND HANDLE WERE LOCATED AND USED WITH NO ISSUES.