MalfunctionHTO
UNIVERSAL DRIVER SHAFT
Received Mar 28, 2006 · Event occurred Mar 14, 2006
Report 2249697-2006-00027 · MDR key 694491
Device
Generic name
Instrument
Manufacturer
Howmedica Osteonics CorpModel number
NACatalog number
2107-1015
Lot number
FZM5710
Product problems
- Device, or device fragments remain in patient
Patient
UNKNOWN
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE END OF THE PRODUCT SHEARED OFF AND WAS LEFT IN PT.