MalfunctionHTT
5.5MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (58X)
Received Nov 16, 2010 · Event occurred Nov 4, 2010
Report 2648666-2010-00460 · MDR key 1908271
Device
Product problems
- Detachment Of Device Component
- Difficult to Remove
- Metal Shedding Debris
Patient
UNK
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE ON THE SHOULDER, METAL SHARDS CAME OFF THE UNIT AND REMAINED IN THE SHOULDER OF THE PT. THE SHARDS COULD NOT BE RETRIEVED. IT WAS FURTHER REPORTED THAT THE SURGEON FELT THAT HE WAS NOT USING MORE PRESSURE THAN USUAL NOR WAS HE APPLYING EXCESS TORQUE TO THE UNIT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PT.
Additional Manufacturer Narrative
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.