(b)(4).Due to the intra-operative malfunction, the cement was not used during the procedure.Per facility, the complainant part was discarded and is not available for evaluation.(b)(6).A 510k number has not yet been assigned to this product.This ous product is similar to a device marketed in the us.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing site: (b)(4).Manufacturing date: september 30, 2015.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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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Manufacturing investigation evaluation: the kit was received in an unpacked and used condition with the paddle blocked in the device.The article was forwarded to the legal manufacturer for evaluation.The returned kit, as well as the retention sample of the same lot number (5g53141), have been analyzed in the laboratory.The conducted investigation on the retention sample showed no deviations regarding handling.A functional test was also performed.The investigation on the complained kit did not identify an obvious root causes.Presumably, various cement impurities, alongside of the mixing axle, led to the jamming, which was likely caused by operating the mixer without adding the monomer.The instructions for use indicate that the mixing process and the movement of the mixing bar, along of the mixing axle, must not be carried out before the monomer has been added.A possible limitation can be avoided by a rapid start to the mixing process after adding the monomer.Since no manufacturing related issues were found, and the specific circumstances of user technique are unknown, the exact cause of failure could not be determined.However, this complaint condition is most likely a result of method of use.No manufacturing related issues were identified and/or confirmed.Device 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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