Product complaint # (b)(4).Device was used for treatment, not diagnosis.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.The sales rep reported an issue of the door was not closing tightly.Per operational and diagnostic, this complaint can be confirmed.During evaluation, it was found that the device was physically broken and bent/dented.There was excessive noise from the device.Also, worn gear was identified.All the defective parts were replaced to resolve the issue.After repair, the device was found to be working according to the specifications.The device being broken/bent might have caused the door was not closing tightly, therefore is a possible root cause of the reported problem.However, with the available information, we cannot determine the definite root cause.A review of lot/batch history for each legacy fms product complaint received by mitek chu is not recommended since legacy manufacturing no longer exists, and it is no longer possible to make process corrections or corrective actions.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.Udi: (b)(4).
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