This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.Reported issue: on september 26, 2019, it was reported that the device does not work properly.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.Dhr review: the device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.Device evaluations results/investigation findings: product review of the electric dermatome by flextronics on october 25, 2019 revealed that when the device was tested the motor speed was not stable and was continuously slowing down.The device was also outside calibration specifications.Repair of the electric dermatome was performed by flextronics on december 3, 2019 which included replacement of the motor and needle bearing.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: the root cause of the reported event could not be specifically determined with the information that was provided.During the product review by flextronics it was noted that the motor speed was not stable and was continuously slowing down.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.Conclusion: review of the information provided during the investigation determined that there are no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.
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