TORNIER
Received Oct 14, 2009 · Event occurred Jul 27, 2009
Report 9610667-2009-00011 · MDR key 1508467
Device
Generic name
Drill Bit, Disposable, 3.5mm Hex
Manufacturer
Tornier Inc.Catalog number
MWB133
Lot number
NOT REPORTED
Product problems
- Detachment Of Device Component
Patient
77 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING THE SURGICAL PROCEDURE FOR A REVERSE SHOULDER ARTHROPLASTY, A DRILL BIT TIP BROKE OFF IN THE GLENOID. THE SURGEON WAS UNABLE TO REMOVE THE DRILL BIT TIP. NO PT INJURY OR NEGATIVE EFFECTS HAVE BEEN REPORTED. THIS SURGICAL INSTRUMENT HAS BEEN RETAINED BY THE CLINICAL FACILITY AND IS NOT AVAILABLE FOR MFG ANALYSIS. THE INSTRUMENT LOT NUMBER HAS NOT BEEN REPORTED. (B)(4).
Additional Manufacturer Narrative
THE DEVICE REPORTED IS AN ORTHOPEDIC SURGICAL INSTRUMENT. THE DEVICE IS NOT INTENDED AS AN IMPLANT. NO ADDITIONAL INFO IS ANTICIPATED FOR THIS EVENT.