Device product
S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
Z-2326-2015
Product summary
- Firm
- Aesculap, Inc.
- Event
- Event 71709
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-2326-2015
Official wording
Reason: A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions for reassembly after reprocessing.
Code information: product: FW103R, all Lots
Distribution pattern: Distributed US (nationwide) and to Canada.
Derived failure modes
-
Unknown
A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions for reassembly after reprocessing.