(b)(4).Investigation: a visual inspection of the femur cutting guide (ns334r) was made.Grooves were found in both boreholes.A visual inspection of the threaded pin (np583r) detected quirks and visible helix traces along with grooves.Also found was a blunt tip.Examination of the boreholes was made with a control gauge and it was determined that they comply with the specifications.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: the root cause of the problem is most probably usage related.Rationale: according to the quality standard a material defect and production error can be excluded.Investigations lead to the assumption that the grooves in both boreholes were caused by a material throw-up of the pin.The quirks and visible helix traces may have been caused by the material throw-up and the additional movement through using the pin.Particles or forces applied during corrections while navigating may have led to a material throw-up.There is a possibility for pre-damage or similar due to previous surgeries.If the instruments are in such poor condition they should no longer be used.The pin and the inner surface of the hole could have been cold welded.We cannot determine the exact cause for the blunt tip.According to the instructions for use (ifu) the following points and warnings much be observed: excerpt from ifu: prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.Do not use the product if it is damaged or defective.Set aside the product if it is damaged.Replace any damaged components immediately with original spare parts.A capa was initiated.Associated medwatch: 9610612-2019-00073.
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