NA

Additional Manufacturer Narrative

STERIS IS NOT THE MANUFACTURER OF THE TWIST DRILL BIT SUBJECT OF THE REPORTED EVENT. STERIS HAS NOTIFIED THE MANUFACTURER, GSOURCE OF THE REPORTED EVENT TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY. AS THE PRODUCT DISTRIBUTOR, STERIS IS SUBMITTING THIS REPORT SOLELY IN RESPONSE TO THE RECEIVED MEDWATCH. THE DEVICE SUBJECT OF THE REPORTED EVENT IS NOT BEING RETURNED FOR EVALUATION. UDI RELATED DATA CLARIFICATION - IT SHOULD BE NOTED THAT THE LOT NUMBER REFERENCED IN THE MEDWATCH REPORT DOES NOT MATCH STERIS DISTRIBUTION RECORDS; THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY VIA MEDWATCH REPORT #(B)(4) THAT THE TIP OF THEIR TWIST DRILL BIT BROKE OFF INSIDE OF THE PATIENT DURING A PATIENT PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.