Device product
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
Z-1932-2013
Product summary
- Event
- Event 64993
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11
- Official record key
device-enforcement:Z-1932-2013
Official wording
Reason: During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Code information: Lot Numbers: 1335201A, 1446101A
Distribution pattern: US Distribution including the states of MA, NV and TX.
Derived failure modes
-
Unknown
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.