Investigation results: visual investigation: in the delivered condition the cups were already screwed off the thread of the nt414r.The first thread of both inserters (nt414r) show little damages.The thread of both cups (nv254t) show no damages or abnormalities.A function test was carried out on both nt414r using the cups supplied: in normal use, i.E.When the cup is screwed onto the thread of the inserter with normal force, it is easy to remove the impactor from the thread of the cup.In the course of the functional test it was found that the little damages on the first thread of both instruments have no influence on the further functionality.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that there are 2 similar complaints against the same lot number(s).Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
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