Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.During investigation the breakage surfaces of the broken remained part on the instrument has been analysed.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.Furthermore the mouth shows several damages on the cutting edge and its lateral parts.Batch history review: the device quality and manufacturing history records for the available lot number has been requested at the responsible q-coordinator of the production plant.The answer is still pending, the 8d-report will be updated upon receipt of the review-confirmation.No similar incidents have been filed with products from this batch.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) 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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