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.Investigation summary the complaint device was received at the service center and evaluated.It was reported that unit didn't seem as if it was working properly and they noticed it over pressurizing.They were able to adjust the pressure and continue on with the case using this unit.Per service reports, this complaint cannot be confirmed.During the service evaluation, no defects were identified.After repair, the device was found to be working according to the specifications.Since the reported condition is not confirmed, the root cause for the reported failure cannot be determined.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated with manufacturing.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 to which this complaint is observed in the field.
|