This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the flow value was not in the range.Per service manual operational and diagnostic, this complaint can be confirmed.It was found during evaluation that the pedal was defective.The complete device was replaced to resolve the issues as foot pedal was deemed not repairable.With the available information, we cannot determine the root cause of the identified failures.The defective pedal would have caused the customer to experience the reported problem.A manufacturing record evaluation was performed for the finished device serial number (b)(6), and no non-conformance was identified.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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