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 confirmed through quality testing.Maximum temperature recorded on the head of the attachment exceeded maximum allowable temperature.The attachment exhibited a temperature increase during free run testing of 61.2°c and under load of 67.4°c.Maximum allowable temperature at the time of testing was 43.2°c.Bur end bearing retainer exhibited crack.This failure would have led to set instability, contributing to the overheating seen during the investigation.Microscopic evaluation revealed moderate gear wear on head-tail and head assemblies.Debris was also noted within the cap and bead cavities and inner components.Corrosion and lack of lubrication was also seen within inner components.
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