Device was used for treatment, not diagnosis.Additional device product code is hwc.(b)(4).(b)(6).(b)(4).510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The subject device has been received and is currently in the evaluation process.A device history record review was performed for the subject device lot number 9804670.Manufacturing location: synthes (b)(4).Date of manufacture: dec 9, 2011.Expiration date: dec 1, 2021.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
A product development investigation was performed for the subject device (expert a2fn nail ø11 r cann l340 tan lig), part number 04.009.448s, lot number 7682325).The subject device was returned with the complaint condition stating the upon visual inspection of the complaint implants it can be seen that the parts are blocked in each other as reported, this thus confirming the complaint description.End-cap (04.009.001s / 9347819): a device history record (dhr) review was performed for the affected lot, (b)(4) parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in february 2015.No non-conformance reports (ncrs) were marked in the dhr during production.Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.Nail (04.009.448s / 7682325): a device history record (dhr) review was performed for the affected lot, (b)(4) parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in december 2011.No ncrs were marked in the dhr during production.Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.Further investigation on the parts has shown that the end-cap is badly damaged around the screw head, as well in the recess.The nail is visible in used condition; the nail is damaged on the proximal end due to the removal attempt.Because of the damage and that the parts are blocked in each other, the complaint relevant dimensions cannot be checked for dimensional accuracy and the exact reason for this occurrence was not able to determined.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.
|