This event has been recorded by zimmer biomet under (b)(4).Current repair.Product evaluation: product review of the air dermatome serial number 107369 by flextronics on 05 june 2020 revealed that the motor speed was slow, unit was out of calibration, and control bar position was not correct.They also found that the swivel was loose, needle bearing worn, and ce mark missing.Product repair: repair of the device was performed by flextronics on 17 june 2020 which included replacement of the following: needle bearing, motor, swivel.The device, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.
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