Device was used for treatment, not diagnosis.
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
The actual device has been returned and is currently pending evaluation.
Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly.
Concomitant medical devices and therapy dates, saw handpiece device, (b)(6) 2022.
Udi: (b)(4).
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This is report 1 of 2 for the same event.
It was reported that during the procedure and while making the anterior femoral cut, the robotic assisted saw interface right (sasi) device was loose and not clamping tight to the saw handpiece device.
It was further observed that the saw handpiece was connecting loosely to the sasi.
It was further reported that the right sasi came unlatched during the cut and it was clamped back quickly with no impact to surgery.
It was reported that the sasi was tested with other saw handpiece devices and found the connection to be loose.
Additionally, the saw handpiece was tested with other sasi's and found the connection to be loose.
Other sasi's with the other saw handpiece device clamped securely.
It was reported that there were no delays in the surgical procedure.
There was patient involvement.
There were no injuries, medical intervention or prolonged hospitalization.
All available information has been disclosed.
If additional information should become available, a supplemental medwatch will be submitted accordingly.
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