TRINITY

Additional Manufacturer Narrative

CASE: (B)(4) COMBINED REPORT. A SIMILAR EVENT OCCURRED (CASE: (B)(4) WAS REPORTED TO CORIN. WHEN THIS EVENT WAS REPORTED, IT WAS STATED THAT A SIMILAR EVENT HAD OCCURRED BEFORE. THE DEVICE DETAILS, SURGERY DATE AND EVENT INFORMATION IS NOT KNOWN AND THUS NO INVESTIGATION CAN BE CONDUCTED. THE APPROPRIATE DEVICE DETAILS ARE UNKNOWN AND THEREFORE, THE RELEVANT DEVICE MANUFACTURING RECORDS CANNOT BE IDENTIFIED OR REVIEWED. THIS CASE IS CONSIDERED CLOSED DUE TO INSUFFICIENT INFORMATION BEING AVAILABLE TO CONDUCT ANY INVESTIGATION, HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED THEN THIS CASE MAY BE RE-OPENED. 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 CANCELLOUS BONE SCREW: A METAL FRAGMENT CAME OFF THE SCREW DURING SURGERY. THIS COMPLAINT WAS REPORTED BY CASE: (B)(4). METAL FRAGMENT WAS CREATED WHEN THE SURGEON USED TRINITY CLUSTER SHELL AND TRINITY SCREW. NO FURTHER INFORMATION WAS PROVIDED FOR THIS EVENT.