Manufacturing site evaluation: product has been received for investigation, fell off mouth part sent in together with instrument.The instrument is in a decontaminated condition.According to the available information, there were no negative consequences for the patient.The instruments upper mouth part is broken investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.During investigation the breakage surfaces of the broken mouth part and the remained part on the instrument have 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.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale: according to the investigation results a material defect and production error can be excluded.Based on the analysis of the breakage surface, most probably the breakage was caused by an overload situation during the surgery.Corrective action: corrective action and preventive action is not necessary.
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