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 stopped working post production testing.Although an actual temperature reading was not captured, a root cause as to why this situation would have occurred could be determined.Both beatings failure, free roaming ball beatings, 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 significant, abrasive wear on the teeth of the gears.All components looked corroded 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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