Investigation results: visual investigation: the product arrived in a clean status with a marked jaw and broken carbide insert.The investigation was carried out visually and microscopically.Here we found a marked jaw and a broken off carbide insert.Additionally we detected brown discoloration and unknown deposits.Furthermore we made a visual inspection of the fracture surface.No anomalies were discovered.Investigations lead to the assumption that the crack was caused due to a stress-corrosion cracking.The brown discoloration could be corrosion.Due to an existing pre-damage or weak point, the reprocessing was breakage-triggering.There is the possibility for a pre-damage due to a mechanical overload situation or an excessive force.This could also be the cause for the broken off carbide insert.The exact cause could not be determined.Batch history review: batch history review is not yet available.In our regular system the device quality and manufacturing history records are not available for such old manufacturing dates regarding this manufacturing date.Therefore the dhr will be checked by the responsible manufacturing department at that time.If the review shows any conspicuities, the report will be updated and actions will be initiated.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) 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 a capa is not necessary.
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