This event has been recorded under zimmer biomet complaint number (b)(4).Udi #: (b)(4).The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.The customer also returned an autoclave case, screwdriver and 1"/2"/3"/4" width plates, for evaluation.Product review of the electric dermatome on september 23, 2019 revealed that the device operated below motor speed specifications.The device was within calibration specifications and the control bar was in the correct position.Repair of the electric dermatome was performed by zimmer biomet surgical on september 23, 2019 which included replacement of the motor, eccentric shaft and bearings.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review it was noted that the device operated below motor speed specifications.It is unknown with the information that was provided how this occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.
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