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 through quality and production testing.Maximum temperature for the attachment head exceeded maximum allowable temperature standards.Both bearings 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 significant, abrasive wear on the teeth of the gears.
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