Investigation: the components have been examined visually and microscope with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the instrument.Here we found a broken off tip.Additionally, we found visible damage and quirks.Furthermore, we made a visual inspection of the fracture surface.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: according to the quality standard a material defect and production error can be excluded.No pores or foreign bodies could be found on the point of rupture.Investigations lead to the assumption that the broken off tip was caused by a mechanical overload situation due to an improper handling.There is the possibility of torsion or high leverage with the instrument and also the possibility for pre-damage or similar due to previous surgeries.The visible damage quirks could have been caused due to other instruments.No capa is necessary.
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