Device product
Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
Z-1957-2013
Product summary
- Event
- Event 64994
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9
- Official record key
device-enforcement:Z-1957-2013
Official wording
Reason: The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
Code information: Lot Number: 011836-0001, 011981-001
Distribution pattern: Distributed in DC and the states of MA, and OK.
Derived failure modes
-
Unknown
The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.