inforMED
MalfunctionHTT

4.0MM 12 FLUTE BARREL BUR- HOLLOW, FORMULA (5BX)

Received Dec 2, 2010 · Event occurred Nov 4, 2010

Report 2648666-2010-00469 · MDR key 1934025

Device

Generic name

Bur

Catalog number

0375941012

Lot number

10236CE2

Product problems

  • Bent
  • Metal Shedding Debris

Patient

UNK

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY, THE BLADE ON THE UNIT BLUNTED AND THE GUARD WAS BENT INTO THE UNIT AND PRODUCED METAL SHAVINGS. IT WAS FURTHER REPORTED THAT THE SURGERY WAS COMPLETED USING ANOTHER UNIT. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES.

Additional Manufacturer Narrative

ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.