This event has been recorded by zimmer biomet under:(b)(4).This medwatch is being filed to relay additional information.The device history record for zimmer skin graft mesher serial number: (b)(6) were 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.On 27 june 2019, it was reported that a mesher had a blade or prong.The customer was asked to return a zimmer skin graft mesher serial number: (b)(6) for evaluation, however, the customer instead decided to purchase a new comb for their device.Because of this, no evaluation or repair was performed and cannot be reviewed as part of the investigation.The device was not returned for evaluation or repair.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 per complaint trending procedure for any adverse trends that may warrant further action.H3 other text : not returned.
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