Part # 03.010.428.Lot # 9810742.Manufacturing site: (b)(4).Release to warehouse date: 08.Mar.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The device was not returned.A photo-investigation was performed on the images.Tfna.Colectivo (b)(4) inspecting the images provided, depth gauge f/lock-scr meas-range-110 was observed to be broken.Thus, the reported condition is confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The complaint condition is being confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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.
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