The reported event was confirmed.Review of dhr, complaint history, capa databases and risk analysis did not identify any discrepancies.No nc/capa had been filed for the item in question.Potential nail breakage had been considered in the risk management file.Potential reasons for nail breakage are listed in the labelling.Physical investigation of the nail revealed it broke in a fatigue manner, originated by material damage at lateral in the posterior web of the proximal drill hole.Additionally, the nail was heavily loaded during the implantation period.Material and manufacturing deficiencies were not detected.X-rays were provided and were presented to a healthcare professional for review.His opinion was (in extracts): ¿very young patient¿seems to be in a very bad overall health status.¿if she is still having alcohol consumption, she may have been very careless with the weight bearing¿.Lag screw placed exactly through the laterally opened fracture.All of this may have contributed to the poor outcome.¿ with available information a deficiency of the device was not verified.The cause of the event was determined being patient related contributed by intra-operative material damage.¿ an unsuitable placement of the lag screw was concluded as root cause and being user related.In case further substantive information becomes available we reserve the right to re-open the investigation with root cause assessment.
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