Device was used for treatment, not diagnosis.Unknown if patient was involved; patient information not available for reporting.Unknown if the issue was detected pre-operatively or intra-operatively.Device is an instrument and is not implanted/explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: 03.010.045/ 7751732.Manufacturing location: (b)(4).Manufacturing date: 20 feb 2012.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
Device was used for treatment, not diagnosis.A customer quality (cq) investigation was performed for the subject device (insert-handle f/expert tn+fn, part number 03.010.045, lot number 7751732).The investigation has shown that the nose on the handle is broken off.The missing fragment was not sent back for investigation.There are also marks on the entire surface visible.The review of the production history revealed that this insertion handle was manufactured in february 2012 according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances and we can only assume that high applied torsional force caused this damage.Although the exact cause cannot be determined, this complaint condition is likely a result of method of use, the complaint is determined not to be a result of a detected product related deficiency.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|