This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the reported event could not be duplicated; however, the machine head and e-ring were damaged and the unit was out of calibration.The machine head, shaft bearings, sleeve bearings, pin, and e-ring were replaced and the unit was calibrated and tested to specifications.Review of the previous repair record identified unrelated repairs to the reported event.The device was tested and found to be functioning to specifications prior to release to the customer.Device is used for treatment.A definitive root cause cannot be determined.
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