Device product
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Z-1030-2019
Product summary
- Event
- Event 82201
- Status
- Terminated
- Classification
- Class II
- Quantity
- 133 total devices
- Official record key
device-enforcement:Z-1030-2019
Official wording
Reason: the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.
Code information: Lot 7EQAB-D, 7ATAB-D
Distribution pattern: distributor and user level
Derived failure modes
-
Unknown
the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.