MalfunctionHTT
5.5MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)
Received May 16, 2012 · Event occurred Apr 24, 2012
Report 2648666-2012-00164 · MDR key 2597685
Device
Generic name
Formula Bur
Manufacturer
Stryker Endoscopy Puerto RicoCatalog number
0375951000
Lot number
12086CE2
Product problems
- Break
Patient
UNK
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BUR UNIT FELL OUT BEFORE THE FIRST USE.
Additional Manufacturer Narrative
UPON RECEIPT OF THE UNIT IT WAS CONFIRMED THAT THE TIP OF THE BUR UNIT WAS BROKEN. ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.