Device product
The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
Z-1744-2015
Product summary
- Event
- Event 71365
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-1744-2015
Official wording
Reason: The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.
Code information: Catalog number: 419500 Lot number: 0101296012
Distribution pattern: Nationwide distribution to MD only
Derived failure modes
-
Unknown
The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.