MalfunctionLXI
FLEX DRILL BIT
Received Oct 7, 2015 · Event occurred Aug 4, 2015
Report 3010536692-2015-01822 · MDR key 5132093
Device
Generic name
Hip Instrument
Manufacturer
Microport Orthopedics Inc.Catalog number
8400-FD03
Lot number
34147
Product problems
- Break
Patient
50 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.
Additional Manufacturer Narrative
THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
ALLEGEDLY THE INSTRUMENT WAS BROKEN EASILY. SURGERY TIME EXTENDED GREATER THAN 30 MINUTES.