This event has been recorded under zimmer biomet complaint number (b)(4).The customer returned an electric dermatome device, serial number (b)(4), for evaluation.The customer also returned the 1"/2"/3"/4" width plates, for evaluation.Product review of the electric dermatome on november 6, 2019 revealed that the calibration was out of specifications at the zero, ten, and twenty settings.The control bar was in the correct position and the motor speed was below specifications and ran erratically.The wires on the cord were exposed.The customer did not return a power supply for evaluation.Repair of the electric dermatome was performed by zimmer biomet surgical on november 6, 2019 which included replacement of the 1.5 inch width plate, plug harness assembly, end cap, o-ring, seal/strain relief, die cast lever, motor, switch, switch mount, motor seal, bearings, internal retaining ring, spring seal, ball plunger, vespel bearings, semi-circle bearings, and set screws.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.While the returned product investigation confirmed that the electric dermatome was malfunctioning, it cannot be determined from the information provided which component or combination of components was causing the issue the customer was experiencing.A number of findings noted during evaluation could have contributed to the reported event such as the calibration being out of specification at the zero, ten and twenty settings, the motor speed was below specifications and ran erratically, and the wires on the cord were exposed.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The device was noted to be functioning as intended after the 1.5 inch width plate, plug harness assembly, end cap, o-ring, seal/strain relief, die cast lever, motor, switch, switch mount, motor seal, bearings, internal retaining ring, spring seal, ball plunger, vespel bearings, semi-circle bearings, and set screws were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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