User fell when stepping down from a terrace on uneven ground and fractured her femur bone necessitating surgical intervention.The fall is considered likely to be related to knee being unable to detect heel strike due to complexity of user's action in a complex environment, however unable to fully confirm root cause.Device was found fully functional and passed all quality checks and user testing.Likelihood of failure leading to hazardous event and resulting in a serious injury is considered to be remote.Issue will continue to be monitored.
|