MalfunctionHTT
STRYKER FORMULA BARREL BUR 12 FLUTE 4MM
Received Jul 31, 2012 · Event occurred Jul 24, 2012
Report 2685856 · MDR key 2685856
Device
Generic name
Reprocessed Stryker Barrel Bur
Manufacturer
Stryker EndoscopyModel number
375-941-012Catalog number
*
Lot number
1918562
Product problems
- Device Operates Differently Than Expected
Patient
54 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, SURGEON WAS USING A 4MM FORMULA BARREL BUR. AFTER APPROXIMATELY 15 MINUTES OF USE TO DECOMPRESS BONE IN SHOULDER, THE SURGEON NOTED THAT THE BUR WAS BURNING THE BONE. THE BUR WAS REMOVED AND REPLACED. THE BUR WAS NOTED TO BE A REPROCESSED PRODUCT. NO PATIENT INJURY OR COMPLICATION.