Investigation results: visual investigation: we made a visual and microscopical inspection of the product.The complained device shows visible traces of use.Furthermore the trail insert was forwarded to the responsible manufacturing department for further investigation.The device shows signs of use.The described error description was checked wthe the following products.The following products were used for this purpose: nk669k 52797287; nv052t 52788983.Result: the function was given with the cup, the ball head and in combination.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: a clear conclusion regarding the root cause for the mentioned failure cannot be determined.The provided device shows no hints regarding a manufacturing or material related error.During the functional test carried out by the responsible manufacturing department, the mentioned failure could not be rectified.Based on the signs of use, it can be assumed that the product has been used several times probably successful, otherwise the product would have been discarded/sorted out long ago.It could be possible that the user inserted the device the wrong way.But this is only speculative.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem is most probably usage-related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigation results, a capa is not necessary.
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