MICRO BUR, OVAL CARBIDE, MEDIUM, 5.5 X 10MM

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING A BUNIONECTOMY PROCEDURE, THIS BUR BROKE IN HALF. THE BROKEN PIECE WAS RETRIEVED AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER BUR. THERE WAS NO PT INJURY OR SURGICAL DELAY WITH THIS EVENT.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: THE PRODUCT AND ITS DETACHED PORTION WERE RECEIVED FOR EVALUATION. A VISUAL EXAMINATION CONFIRMED THE REPORTED PROBLEM AND FOUND THE BUR BROKEN IN THREE PLACES. FURTHER INSPECTION FOUND NO DEFECTS IN THE MATERIAL, GOUGES OR GALLING. ALL PIECES HAVE BEEN SENT TO A THIRD PARTY LAB FOR ADD'L ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT ONCE THE RESULTS BECOME AVAILABLE. THE HANDPIECE INSTRUCTION MANUAL WARNS THE USER OF THE FOLLOWING: DO NOT OPERATE THE DRILL WITHOUT THE APPROPRIATE BUR GUARD. ALWAYS USE A BUR OF THE PROPER LENGTH. THE TIP OF THE BUR GUARD SHOULD COVER THE SAFE LINE ON THE BUR, IF APPLICABLE. WITHOUT THE STABILIZATION THAT THE PROPER BUR GUARD PROVIDES, THE BUR CAN BREAK AND BE PROPELLED WITH GREAT FORCE. THE USER FACILITY WAS UNABLE TO CONFIRM THAT A BUR GUARD WAS IN USE AT THE TIME OF THIS EVENT.