ORTHOFIX

Description of Event or Problem

"A DRILL BIT BROKE IN HALF DURING ITS USE IN SURGERY BY DR. [REDACTED NAME]. THE 2 PIECES WERE GATHERED AND IT APPEARS THAT IT WAS A CLEAN BREAK. CONTINUOUS FLOUROSCOPY WAS IN USE DURING THE PROCEDURE WITH NO EVIDENT RETENTION. AN X-RAY WILL BE OBTAINED AT THE CONCLUSION OF THE SURGERY. THE LOT NUMBER DID NOT SCAN INTO SUPPLIES. THE REPS WERE PRESENT AND AWARE OF BREAK. THEY DID NOT RECEIVE THE BROKEN BIT, IT WAS DISCARDED. IN SUPPLIES IT WAS DOCUMENTED AS USED AND NOT WASTED AS IT SHOULD HAVE BEEN." MANUFACTURER RESPONSE FOR DISTAL DRILL BIT 4.5MM, DISTAL DRILL BIT 4.5MM (PER SITE REPORTER) REPS PRESENT.