Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Dentsply was not able to verify the complaint as the temperatures during quality testing did not exceed maximum temperature specification.The returned attachment was tested by manufacturing personnel and met all production specification.Quality personnel then investigated the attachment.The attachment maximum temperature while free running with coolant spray off was 38.6°c and 37.8°c under load testing with coolant spray on.The attachment was then disassembled and microscopically evaluated.Microscopic evaluation revealed moderate gear wear on the head-tail and head assemblies.Significant debris was observed inside the head and cap cavities and inner components.All components looked dry with no evidence of lubrication.The lack of lubrication may also have caused friction and as a result increase the temperature causing heat reported in the complaint.
|