This event has been recorded by zimmer biomet under (b)(4).On january 21, 2020, it was reported that the engine stops.The customer returned an electric dermatome device, serial number (b)(6), for evaluation.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.Product review of the electric dermatome by flextronics on february 25, 2020 revealed that the insulation of the cable was damaged and the needle bearing was missing.The external e-ring, reciprocating arm, neckpiece and spring seal were worn.The unit was out of calibration and the control bar was not in the correct position.It was also noted that the motor was intermittently functioning.Repair of the electric dermatome was performed by flextronics on march 2, 2020 which included replacement of the plug harness assembly, needle bearing, external e-ring, reciprocating arm, neckpiece, spring seal, motor and screws.Electric dermatome, serial number (b)(6), 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 by flextronics it was noted that the motor was intermittently functioning.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 (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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