This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The device history record and previous repair record for zimmer air dermatome serial number (b)(6) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with the device.The record reviews found no issues with the device and all verifications, inspections, and tests were successfully completed.The reported event was confirmed by the service technician who performed the evaluation.On (b)(6) 2019, it was reported that a dermatome was losing air.The customer returned a zimmer air dermatome serial number (b)(6) for evaluation.Evaluation of the device noted that the dermatome had a damaged machined head, the needle bearing, screws, and reciprocating arm were worn, that the device ran below motor speed specifications, and had a loose swivel.Upon further evaluation, it was noted that the part number was illegible and that there was no ce mark on the device.At the time of the investigation, the device was put on a quotation hold and the device has yet to be repaired.The device was tested and inspected.While the service technician found that the swivel was loose, which would allow air to leak from the device and therefore cause the motor to run below motor speed specifications, it cannot be determined from the information provided as to what caused the swivel to loosen from the body of the dermatome.As such, a specific root cause of the reported event cannot be determined.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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