2.1 MM FIXED DEPTH DRILL 12 MM (STAINLEES STEEL, TI-6AI-4V ELI)
Received Apr 10, 2018 · Event occurred Mar 13, 2018
Report 2027467-2018-00018 · MDR key 7418519
Device
Generic name
Htw
Manufacturer
Alphatec Spine IncModel number
63928-12Catalog number
63928-12
Lot number
7117915
Product problems
- Unintended Movement
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION INTO THE RETURNED INSTRUMENT FOUND THAT THE DRILL STOP MEASURED APPROXIMATELY .012" MORE PROXIMAL THAN PRINT REQUIREMENTS/TOLERANCE. THIS ALLOWED THE DRILL TO BE INSERTED THROUGH THE DRILL GUIDE AND THE TIP TO EXTEND AN ADDITIONAL .3048MM FURTHER THAN INTENDED. INSPECTION DID NOT REVEALED ANY EVIDENCE INDICATING THE FIXED STOP HAD MIGRATED OR SLIPPED FROM ITS MANUFACTURED POSITION.
Description of Event or Problem
THE STOP ON THIS INSTRUMENT IS MOVING WHEN PLACED INSIDE OTHER INSTRUMENT. NOTICED WHEN DOING ROUTINE INSPECTION. DID NOT OCCUR AT HOSPITAL.