Investigation results: visual investigation: the product arrived in a very used, decontaminated condition.The movable, upper mouth was broken off and was not available to us for examination.During the examination of the instrument, there were found heavy signs of use in the form of scuff marks, knock marks, and scratches.Silicate coatings, most likely from reconditioning, can be found on the entire surface.The fracture surface showed a force fracture.On the opposite side (fixed jaw) there is damage to the teeth.The hardness test resulted in a value which meets the 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 no 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)) according to din en iso 14971 is still acceptable.Explanation and rationale: according to the quality standard, a material defect and a production defect can be ruled out with a high degree of probability.There are no indications of previous damage or similar.In order to be able to make a more precise statement, the broken jaw should be made available for examination.Since this instrument was not delivered in this condition because they do not comply with the aag standard, the cause can in all probability be found in the handling, but this cannot be clearly proven.The reason for the deviation cannot be determined.Conclusion and measures / preventive measures: based upon the investigation results the root cause is most probably caused by an overload situation because these instruments are sensitive to lateral loads such as torsional and lever forces or impacts.Based upon the investigations results a capa is not necessary.
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