Updated h6 codes based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: we made a visual inspection of the product.Here we found the broken instrument on the jaw male.Here we detected brown and dark discolorations and signs of an intercrystalline fracture.The cause of the damage is due to several factors that have led to the fracture.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the leading device(s) lot number(s) from the quality coordinator of the production plant.The results of the review will be documented.If the review shows any conspicuities, the report will be updated and actions will be initiated.Review of the complaint history revealed that two similar complaints have been 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 3(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: investigations lead to the assumption that the breakage was caused by stress-corrosion cracking.Possibly a pre-damage could caused due to a manufacturing deviation by unfavorable production-related circumstances, such as sharp-edged milling transitions, as well as critical material tensile stress conditions due to straightening work.It appears that the brown discolorations are rust / corrosion and the dark discoloration are signs of an old crack.Additionally it appears that the cracks are ferrite rusticities / ferrite microstructures.Due to the existing pre-damage or weak point, the reprocessing was fracture-triggering.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the reported issue is most probably reprocessing - related, or manufacturing, or design-related failure.Based upon the investigations results a change request was initiated.
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