(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 visible helix traces and a visible damaged tip.Also grooves in both boreholes were found.Examination of the boreholes was made with a control gauge and it was determined that they and not complying with the specifications.Batch history review: ns334r: the device quality and manufacturing history records have been checked for the lot number (4508169307) and found to be according to the specification, valid at the time of production.Three similar incidents have been filed with a product from the batch (4508169307).Conclusion and root cause: the root cause of the problem is most probably usage and manufacturing related.Rationale: investigations lead to the assumption that the grooves in both boreholes were caused by a failure during manufacturing and additional by a material throw-up of the pin.The quirks and visible helix traces may have been caused by the grooves, 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.Due to a material throw-up and grooves in the boreholes, there is the possibility that the pin and the inner surface of the hole could have been cold welded.We cannot determine the exact cause for the visible damaged 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: 9610612-2019-00075.
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