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 he initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.Multiple follow ups were performed to obtain more information but no response was received.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported event.A manufacturing record evaluation was performed for the finished device lot number (6l75729), and no non-conformances were identified.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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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