Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.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.The subject device has been received.The investigation could not be completed; no conclusion could be drawn, as the subject device is entering the complaint system.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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An investigation summary was performed.Our investigation of the complaint articles has shown that: one driving cap (part # 03.010.523, lot # 8953354) was returned for investigation.The driving cap shows regular use, with hammer marks and gouges on the head of the device consistent with high impact force.The distal threaded tip of the of the driving cap is broken off and was returned stuck in the returned insertion handle (part # 03.010.440, lot # 14-6678).Although the exact cause for the complaint condition could not be determined, the damage appears to be the result of hammering on the device after it was cross threaded or before it was fully seated against the insertion handle and thus deforming the threads.Subsequently, the force necessary to dislodge the weakened driving cap caused the tip to break.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint condition is 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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