Patient information not available for reporting.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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Device history records review was completed for part# 319.091, lot# 6414742.Manufacturing location: (b)(4), release to warehouse date: jun 22, 2010.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.The returned depth gauge shows several mechanical damages on the surface.Furthermore, the anodized color was found partially disappeared.The returned depth gauge was tested and the complaint condition could be confirmed, as it is rough running as reported.The instrument was lubricated with synthes special oil during the investigation and was then freely movable as required.The problem as per complaint description could not be duplicated anymore.Investigation has shown that the complaint condition is confirmed.It is assumed that the instrument was not lubricated as per the instructions provided by the manufacturer.Based on these findings, it was concluded that the cause of failure was not due to any manufacturing non-conformances.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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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