Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Initial reporter phone number: (b)(6).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device had stains and scratches on it, was confirmed.It was found that the device was dirty and produced a bad image.Further, the light post, optics and the distal tip were found to be damaged and the shaft was bent.The damaged components of the device were replaced and the device was cleaned, tested and found to be fully functional.User mishandling and lack of maintenance of the device is responsible for the physical damage to the device and the presence of stains on the device.A manufacturing record evaluation was performed for the finished device (serial number: (b)(4), and no non-conformances were 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.Udi: (b)(4).
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