BURR

Description of Event or Problem

"IT WAS REPORTED THAT DURING TESTING OF A STRYKER CORE IMPACTION DRILL BY THE CUSTOMER PRIOR TO A PROCEDURE, IT WAS NOTED THERE WAS A BROKEN BUR INSIDE THE HANDPIECE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, MEDICAL INTERVENTION OR DELAYS AS A RESULT OF THIS EVENT" STRYKER INSTRUMENTS CONDUCTED A COMPLAINT INVESTIGATION AS A RESULT OF THIS INFORMATION (STRYKER REFERENCE (B)(4)). HOWEVER, THROUGH THE COURSE OF THE INVESTIGATION, IT WAS CONFIRMED THAT THE BROKEN BUR WAS NOT A STRYKER BUR. THE MANUFACTURER OF THE BUR, SS WHITE BURS INC. HAS BEEN NOTIFIED OF THIS EVENT ON (B)(6) 2012. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).