Upon review of the investigation, the complaint has been re-assessed and is now considered to be non-reportable; severity is now 2(5) reduced from 4(5).Investigation: visual investigation: we found that one cutting edge of the gouge has broken off.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.On the surface of the instrument, we found signs of use in the form of impact, scratches and scuff marks as well as residues from reconditioning.In addition, we performed a hardness test with the results corresponding to specifications.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 two similar complaints filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: considering that the instrument was not delivered in this condition, it is almost certain that a "mechanical" overload situation led to the breakage.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 investigation results a capa is not necessary.
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