Patient weight not available for reporting.Device is an instrument and is not implanted/explanted.Concomitant device therapy date is not known.Subject device has been received and is currently in the evaluation process.Dhr review was completed.No ncrs 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.Manufacturing site: (b)(4).Manufacturing date: 06.Feb.2015.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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A product investigation was completed: a visual inspection under 5x magnification, drawing review, and dhr review were performed as part of this investigation.This complaint is confirmed.The locking tip on the distal end of the device is broken and missing.Missing fragment was left in the patient.Whether this complaint can be replicated is not applicable for this complaint condition as the returned device is already damaged.No new malfunctions were identified as a result of the investigation.The returned helical blade/screw extractor is a reusable instrument available for use tfna system.The locking tip on the distal end of the device is broken and missing.Missing fragment was left in the patient.The overall balance of the device looked in a good condition with minimal surface wear.A review of the current design drawing and available history for the top level drawing for the screwdriver was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The device¿s application involves use of hammer.Most likely due to application of excessive and/or off-axis force during threading/extraction of the implanted helical blade due to boney ingrowth around the helical blade.Improper hammering technique could also contribute to the complaint condition.In the absence of the further details regarding the surgery, it is not possible to determine the exact root cause of the issue.No non-conformance reports 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.This indicates that all the manufacturing processes were followed as per requirement ensuring product material and hardness at the time of manufacturing.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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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