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The account reported a broken blade upon opening, and the complaint transcript states the issue did not occur during use and no injury occurred.A photo was received for the investigation; device history records were reviewed with no non-conformances noted, and the finished good pack build was reviewed with no issues identified that would contribute to the reported issue.Based on the investigation and photo evaluation, the reported issue was confirmed.The root cause was attributed to a supplier-related product issue associated with the component manufacturing process, as the component is received prepackaged and does not undergo any additional manipulation during the assembly process; the vendor reviewed the lot information and found it was manufactured, inspected, and packaged following established and validated procedures and processes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
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