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.The reported complaint was not confirmed through production and quality testing.The returned attachment was tested by manufacturing personnel and met all production specifications.Quality personnel then investigated the attachment.The attachment maximum temperature while free running with coolant spray off was 34.5°c and 35.2°c under load testing with coolant spray on.These temperature did not exceeded for maximum allowable temperature.The attachment was then disassembled and microscopically evaluated.Both bearing retainers looked good.The gears also looked good with only minor wear.Some debris was observed inside the head and cap cavities and bearing components.
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