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 production & quality testing.Maximum temperature for the attachment head exceeded maximum allowable temperature during testing.During examination of the internal components, it was discovered that the parts all were dry and lacked lubrication.The lack of lubrication may have caused accelerated wear on internal components due to increased friction.This accelerated wear then could have caused critical component tolerances to open up beyond specification.This in tum could cause the wear to accelerate at even a faster rate.Eventually, failure of the bur end bearings can cause instability around the vertical axis of the set assembly causing the heat generated in the complaint.
|