This incident has been recorded under (b)(4).Review of the most recent repair record determined that the machined head was damaged, the unit was out of calibration, the motor speed was unstable, and the thickness control lever, fine adjustment cams, bearings, housing, swivel, gears, poppet, hinge and gasket needed to be replaced.The machined head, thickness control lever, cams, bearings, neck, housing, eccentric shaft, motor, swivel, gears, poppet assembly, hinge, and gasket were replace, and the unit was recalibrated to resolve the reported issue.A definitive root cause cannot be determined.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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