Investigation results: visual investigation: at the first sight the screwdriver shows no damages.At a closely look we found, that the tip was twiste.We made a visual inspection of the screwdriver, especially the tip.Here we found, that the tip is twisted clockwis.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 is one similar complaints against the same lot number(s) in this xc.The review of risk assessment revealed that the overall risk level (severity 4(5) probability of occurrence 3(10)) according to din en iso 14971 is still acceptable.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 there is capa is not necessary.Associated medwatches: 9610612-2020-00946, 9610612-2020-00947.
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