inforMED
MalfunctionHTT

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

Received Apr 24, 2012 · Event occurred Apr 2, 2012

Report 2648666-2012-00130 · MDR key 2556947

Device

Generic name

Formula Bur

Catalog number

0375941012

Lot number

NA

Product problems

  • Overheating of Device

Patient

UNK

  • Burn(s)

Narrative

Additional Manufacturer Narrative

ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE SHAFT OF THE BARREL BUR UNIT HEATED UP. FURTHER, AT THE ENTRY POINT THE PT'S SKIN WAS BURNED. IT WAS FURTHER REPORTED THAT THE ACCOUNT IS NOT SURE WHICH PRODUCT CAUSED THE BURN.