Investigation: used test and analysis equipment; -keyence-vhx 600 d; -panasonic dmc tz8 digital camera.We made a visual inspection of the cutting edge of the pin.It was clear to see, that the pin was not cut correctly.The pin cut skewed and through the fixation rim, so a fixation of the upper disc was not possible.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.Conclusion and root cause: the root cause of the problem is most probably user related.Rational: the ifu contains clear guidlines for inserting the implant and cutting the pin.The risk of coming off the pin during wrong handling is mentioned.No capa is necessary.
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