inforMED
MalfunctionHTT

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

Received Apr 27, 2009 · Event occurred Mar 13, 2009

Report 2648666-2009-00071 · MDR key 1431778

Device

Generic name

Bur

Catalog number

0375941012

Lot number

09044CE2

Product problems

  • Metal Shedding Debris

Patient

UNK

  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING THE 4MM BUR, THERE WERE SHAVINGS THAT CAME OFF IN THE PT'S SHOULDER. ANOTHER BUR WAS AVAILABLE AND PROCEDURE WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.