PANTERA PLATE SYSTEM, INSTRUMENTATION
Received Oct 18, 2013 · Event occurred Sep 18, 2013
Report 3008747271-2013-00003 · MDR key 3481877
Device
Generic name
Drill Bitdrill Guide
Manufacturer
Toby OrthopaedicsModel number
TO-25-DB-110Catalog number
TO-25-DB-110
Lot number
1100250504
Product problems
- Break
- Use of Device Problem
- Mechanical Jam
Patient
Not reported
- Fracture, Arm
Narrative
Description of Event or Problem
DURING A HUMERUS FRACTURE FIXATION SURGERY, A DRILL BIT BROKE INSIDE OF THE DRILL GUIDE.
Additional Manufacturer Narrative
DURING A PANTERA SHOULDER SURGERY, THE 2.5MM X 110MM DRILL BIT SEIZED INSIDE THE 2.5/3.5MM DRILL GUIDE (I.E. TISSUE PROTECTOR) AND BROKE INSIDE THE GUIDE CANNULA. A 21MM LENGTH OF THE END OF THE DRILL BIT IS PROTRUDING FROM THE END OF THE DRILL GUIDE, AND THE DRILL BIT CUTTING SURFACES ARE VISIBLY DAMAGED. THE DRILL BIT TIP IS EXTREMELY DULL AND SHOWS SIGNS OF EXCESSIVE USE. THE DRILL BIT CUTTING SURFACES HAVE BEEN DAMAGED BY A SHARP METALLIC OBJECT. THE TIP OF THE DRILL BIT PROTRUDING FROM THE GUIDE IS VISIBLY BENT.
Remedial action
- Inspection