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 and is currently in the evaluation process.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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Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (6.0mm/10.0mm stepped drill bitcannulated/large qc/435mm, part number 357.403, lot number up49686).The subject device was received with the following complaint condition reporting that ¿the tip of the drill broke off while the surgeon was drilling the femoral head during a trochanteric fixation nail (tfn) surgery on (b)(6) 2016.The surgeon was able to retrieve the broken piece and finish the case without the drill bit¿.The 357.403 6.0mm/10.0mm stepped cannulated drill bit is an instrument routinely used in the titanium trochanteric fixation nail system per the technique guide.Upon visual inspection the complaint condition is confirmed; the most distal step of the drill bit has entirely sheared off at a slight angle.The balance of the returned device is in fairly worn condition with markings and other signs of wear along its length.Although the root cause could not be definitively determined, it is likely that wear from over 11+ years of consistent use has led to this complaint condition.The associated product drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.As previously reported, the device history review identified no ncrs, mrrs or complaint related issues.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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