MalfunctionHTT
FORMULA
Received Aug 21, 2009 · Event occurred Aug 14, 2009
Report 1465451 · MDR key 1465451
Device
Generic name
Shaver Blade, Orthopedic, Barrel Bur
Manufacturer
Ascent Healthcare SolutionsModel number
*Catalog number
375-941-000
Lot number
676230
Product problems
- Metal Shedding Debris
Patient
61 YR
- No Information
Narrative
Description of Event or Problem
DURING USE, A LOT OF METAL DEBRIS WAS SEEN FLOATING; PRESUMED TO BE FROM THE BUR. THE DEBRIS WAS SUCTIONED OUT.