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 35.4 degree celsius and 46.0 degree celsius under load testing with coolant spray on.These temperature did not exceeded maximum allowable temperature.The attachment was then disassembled and microscopically evaluated.Bur end bearing failure, free roaming ball bearings and excessive debris most likely created friction within the head which resulted in temperature increase.It is reasonable to suspect gear function was compromised by the added debris inside the head which is evident from the wear on the teeth of the gears.
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