BUR, SURGICAL, GENERAL AND PLASTIC SURGERY

Description of Event or Problem

FLOOR NOTICED THE BUR BEING BROKEN OFF INSIDE THE ATTACHMENT. THE CUSTOMER ALSO STATED PIECE BROKEN INSIDE, DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, MEDICAL INTERVENTION, OR DELAY. STRYKER INSTRUMENTS CONDUCTED A COMPLAINT INVESTIGATION AS A RESULT OF THIS INFORMATION (STRYKER REFERENCE (B)(6) ). HOWEVER, THROUGH THE COURSE OF THE INVESTIGATION, IT WAS CONFIRMED THAT THE BROKEN BUR WAS NOT A STRYKER BUR. THE MANUFACTURER OF THE BUR, KOMET-BRASSELER 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).