End of afternoon, the surgeon had issue to distract the knee with the themis.The instrument was introduced in extension, the surgeon was supporting the back of the knee but when he was quizzing the handle to distract the spring was compressing (up to maximum) but the tenser was not applying any tension on the articulation (he was not moving); the tenser had space in the articulation, it was moving a bit but was not distracting.Out side the knee the tenser was distracting when squeezing the handle but it was a bit difficult to bring it back to 0 and when the sales rep was mounting it she filled difficult to put the femoral part in the tibial part.This problem happened already once a few week ago with the same problem.But they were not thinking of issue with the themis (see complaint (b)(4)).The sales rep come on (b)(6) 2021 to see what was happening.It was a right knee.No additional time of the surgery and no negative effect for the patient the surgeon used the spacer bock to check the spaces.The themis is on consignment, it will be sent back to saint priest for investigation.(b)(6) 2021 the surgeon did a second knee with themis and it works well.
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Product complaint (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Additional complaint information, monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history lot: a manufacturing records evaluation (mre) was not performed, as no lot number was provided for this device.
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