Reportedly there was no patient involvement.Udi: (b)(4).Device is an instrument and is not implanted/explanted.Contact phone number: (b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.A product investigation was completed: a visual inspection under 5x magnification, functional test, drawing review, and dimensional analysis were performed as part of this investigation.A definitive root cause cannot be identified with the limited complaint details.No new, unique or different patient harms were identified as a result of this evaluation.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.The device was returned with an illegible etch however the design is consistent with a before november 03, 2011 design.The cutting edges were dull and the proximal coupling had sheared off from its base.The broken fragment was not returned.Relevant dimensions could not be measured due to the nature of the damage however it is unlikely that the design contributed to the complaint condition.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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