Investigation: used test and analysis equipment; keyence-vhx 600 d microscope; (b)(4) digital camera.We made a visual inspection of the pin in the lower disc.Here we found a slightly skewed cutting edge with a damaged uppermost fixation rim.Next we investigated the upper disc.The disc is completely bent from inside to the outside.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 pin was skew cut.One of the spring segments couldn't get fixed, the disc seems loose.The surgeon tried to take down the disc, causing the disc to bend (the other spring segments stuck at the fixation rim).The ifu contains clear guidelines for inserting the implant and cutting the pin.The risk of coming off the pin during incorrect handling is mentioned.No capa is necessary.
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