TRINITY

Additional Manufacturer Narrative

(B)(4) INITIAL REPORT. ADDITIONAL INFORMATION INCLUDING; OPERATIVE NOTES, AN UPDATE ON THE PATIENT, WAS ALL THE DEBRIS TAKEN OUT OF THE PATIENT, POST OP X-RAYS & PHOTOS OF THE DEVICE 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. 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

DURING SURGERY A TRINITY STD INTRODUCER/IMPACTOR HANDLE DISENGAGED FROM THE HANDLE AND BECAME STUCK IN THE CUP IN SITU. WHILST STRUGGLING TO REMOVE THE HANDLE, DEBRIS FELL IN THE OPERATIVE WOUND.