inforMED
MalfunctionEJL

BRASSELER USA CARBIDE BUR

Received Aug 24, 2016 · Event occurred Jul 25, 2016

Report 1032227-2016-00009 · MDR key 5901619

Device

Generic name

Dental Carbide Bur

Model number

H245.31.008

Product problems

  • No Audible Prompt/Feedback
  • No Audible Prompt/Feedback

Patient

33 YR

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT A BUR WAS BEING USED BY A STUDENT DURING A DEMONSTRATION AND BUR HIT THE DOCTORS ARM NEAR THE ELBOW JUST UNDER THE TRICEP AND LODGED THERE. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE DOCTOR TO FOLLOW UP AND OBTAIN ADDITIONAL INFORMATION, BUT NO INFORMATION WAS RECEIVED. NO PRODUCT RETURNED, NO LOT NUMBER PROVIDED, OR ADDITIONAL SALES INFORMATION AVAILABLE. WE WERE UNABLE TO CONFIRM IF THE BUR WAS PURCHASED FROM BRASSELER USA. PRIOR TESTING OF SIMILAR BURS FOUND SAMPLES OF THE BUR PASSED ISO NECK STRENGTH TESTING. BURS MAY BREAK IF SUBJECTED TO EXCESSIVE FORCE OR PRESSURE. NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

DOCTOR WAS TEACHING A DENTAL COURSE. STUDENT WAS USING THE BUR ON A PLASTIC TOOTH DURING DEMONSTRATION WHEN DOCTOR TURNED THE BUR HIT THE DOCTOR'S ARM. THE BUR IS LODGED IN THE ARM NEAR THE ELBOW JUST UNDER DOCTOR'S TRICEP. THE DOCTOR BELIEVES THAT IT MAY BE ABOUT 3MM (JUST THE HEAD OF THE BUR). SHE SAID THAT IT IS A POSSIBILITY THAT A PORTION OF THE TIP WAS BURNT FROM WORKING ON THE PLASTIC TOOTH. NO ADDITIONAL INFORMATION WAS DISCLOSED BY THE DOCTOR.