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 complaint was verified.Maximum temperature exceeded the specified temperature limit.The attachment exhibited temperature increase during free run testing of 37.2 c and load testing of 48.1 c.The exterior of the attachment did not show any major wear.Microscopic evaluation revealed moderate gear wear on the head-tail and head assemblies and detachment and subsequent lodging of the cap end bearing retainers in the cap cavity.This would have led to set instability, contributing to the overheating seen during the investigation.The interior of the head cavity and gears were dry and did not show signs of lubrication.
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