inforMED
MalfunctionHTT

5.0MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)

Received Mar 2, 2010 · Event occurred Feb 10, 2010

Report 2648666-2010-00102 · MDR key 1632454

Device

Generic name

Bur

Catalog number

0375951100

Lot number

09124CE2

Product problems

  • Break

Patient

UNK

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE INNER BUR BROKE. THE CUSTOMER RETURNED AN UNOPENED PACKAGE OF THE SAME DEVICE. THE PROCEDURE WAS NOT DELAYED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.