5.5MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SUBACROMIAL DECOMPRESSION PROCEDURE, THE UNIT WAS BEING USED TO SHAVE AWAY BONE. THE METAL TUBE THAT HOUSES THE UNIT BECAME EXTREMELY HOT DUE TO THE FAST MOVEMENT OF THE UNIT INSIDE. IT WAS FURTHER REPORTED THAT AS THE UNIT WAS ANGLED DOWN TO GET INTO THE JOINT SPACE, THE UNIT MADE CONTACT WITH THE SKIN OF THE PT. A FIRST DEGREE BURN THE SIZE OF A ONE PENCE PIECE APPEARED ON THE AUXILIARY FOSSA OF THE PT. IT WAS FURTHER REPORTED THAT THE BURN WOULD LIKELY LEAVE A SCAR. HOWEVER, THE PT DID NOT REQUIRE FURTHER TREATMENT. THE PROCEDURE WAS COMPLETED AND NO OTHER ADVERSE CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS IT WAS DISCARDED. THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE POSSIBLE ROOT CAUSES OF THE REPORTED FAILURE INCLUDE THE FOLLOWING: WRONG AMOUNT OF GREASE IN THE PRODUCT; HIGH FRICTION DUE TO COMPONENT INTERACTION (SURFACE NOT SMOOTH, CLEARANCE BETWEEN BUR AND SLEEVE); POOR SUCTION CAUSING THE PRODUCT NOT TO COOL DOWN; INSULATION DOES NOT WORK CORRECTLY; ASSEMBLY ERROR. IN SUM, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AS THE PRODUCT WAS DISCARDED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.