This event is recorded by zimmer biomet under (b)(4).Product review of the air dermatome serial number (b)(4) by (b)(6) on 7 may 2020 revealed that the complaint could not be duplicated.They found that the motor was jumpy, control bar was not in the correct position, and the calibration was out at the 0 and 30 reading.Repair of the device was performed by dover on 7 may 2020 which included replacement of the following: the handpiece was replaced due to damage received during repair, the swivel, motor, gears, planetary shaft, spring seal, and various bearings were replaced.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.Review of complaint history found no additional related issues for this item and the reported part and lot combination.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is not confirmed.
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It has been reported that the unit was unable to properly sterilize.There was blood in crevices that cannot be cleaned.It sounds like either the dermatome was opened and there was blood present in/on it, or when being dismantled for cleaning there was blood in places that they can¿t reach.During the investigation, it was discovered that the motor was jumpy.No adverse events were reported as a result of this malfunction.
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