inforMED
MalfunctionHTT

4.0MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)

Received Aug 27, 2008 · Event occurred Jul 30, 2008

Report 2648666-2008-00095 · MDR key 1139196

Device

Generic name

Bur

Catalog number

0375941000

Lot number

08161CE2

Product problems

  • Flaked
  • Device, removal of (non-implant)

Patient

UNK

  • Foreign body, removal of
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE SHAVINGS ONTO THE SHOULDER FROM THE BUR DURING A DECOMPRESSION CASE. THE FLAKES WERE FLUSHED OUT AND SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SAME BUR.

Additional Manufacturer Narrative

ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.