MalfunctionHTO
UNIVERSAL DRIVER SHAFT
Received Aug 21, 2003 · Event occurred Jul 21, 2003
Report 2243265-2003-00066 · MDR key 480219
Device
Generic name
Instrument
Manufacturer
Howmedica Osteonics Corp.Model number
NACatalog number
2107-1015
Lot number
FXH211
Product problems
- Device remains implanted
- Tip breakage
Patient
62 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DURING IMPLANTING OF A TRIDENT AD SHELL, THE TIP OF THE INSTRUMENT BROKE OFF AND REMAINS IN THE HEAD OF THE SCREW.
Remedial action
- Other