(b)(4).Investigation: a visual inspection of the femur cutting guide (ns334r) was made and of the threaded pin (np586r).Here we found visible helix traces were found.Additionally a visible damaged tip was detected and grooves in the borehole was discovered.The boreholes were examined with a control gauge and it was determined that they are not complying with our 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.Conclusion and root cause: the root cause of the problem is most probably manufacturing related.Rationale: investigations lead to the assumption that the grooves in the boreholes were caused by a failure during manufacturing.The quirks and visible helix traces may have been caused by the by the grooves, a 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 borehole, 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: 9610612-2019-00074.
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