Investigation: used test and analysis equipment: microscope "keyence- vhx 5000" a visual inspection was performed.It was clearly visible, that the pin of the lower disk was cut too short near the disc, the last catch is completely cut off.So a fixation of the clap is not possible and the upper disc came off.Batch history review: the manufacturing documents have been checked and found to be according to specification which was valid during the time of production.Conclusion and root cause: the root cause for the problem is user related.Rational: usually, if the diameter of the hole is correct, it is not possible to get the discs so close together that it is possible to cut so low, or the bone was to thin for using this system corrective action: according to (b)(4) there is no capa necessary.
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