MalfunctionHTT
5.0MM 6 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)
Received May 30, 2012 · Event occurred May 17, 2012
Report 2648666-2012-00187 · MDR key 2622141
Device
Generic name
Formula Bur
Manufacturer
Stryker Endoscopy Puerto RicoCatalog number
0375951100
Lot number
12039CE2
Product problems
- Device Contamination with Chemical or Other Material
Patient
UNK
- No Information
Narrative
Additional Manufacturer Narrative
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT FOREIGN MATERIAL WAS INSIDE THE STERILE PACKAGE OF THE UNIT.