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.Functional quality testing was not performed since the attachment was not working as received.An actual temperature reading was also not captured due to non-working condition of the returned attachment.A root cause as to why this situation could have occurred could be determined based on quality observations.Bearing retainer's failure, free roaming ball bearings and excessive debris most likely created friction within the head which resulted in temperature increase.Gear function was also compromised inside of the head which is evident from the wear on the teeth of the gears.All components looked dry with no evidence of lubrication.Additionally, the attachment failed all production requirements with the exception of illumination testing (sound testing was not performed).
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