Model Number 317.260 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/29/2014 |
Event Type
malfunction
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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a drill bit breakage occurred of the air pen drive engine.After breakage detection, it was detected a small drill fragment inside of the patient and it was removed.The drill was replaced and the procedure was continued.It was reported that the mf cortex screw broke during the application, and the fragment was removed and it was discarded.This is report 2 of 3 for complaint (b)(4).
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Manufacturer Narrative
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Additional product codes: erl, hbe.Lot number provided as f-13802, but could not be confirmed.Device is an instrument and is not implanted/explanted.Investigation could not be completed, no conclusion could be drawn as no device was returned.Review of manufacturing records has been requested.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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Manufacturer Narrative
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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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Manufacturer Narrative
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Additional narrative: a device history review was conducted.The report indicates that 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.A manufacturing investigation was conducted.The report indicates that the investigation of the complained drill bit shows that the tip is broken off.Unfortunately we are not able to determine the exact cause which has lead to this occurrence.Too much mechanical force had been applied during the surgery.We are aware that this is very delicate drill bit which require extra caution during use.No product fault could be detected.The measurable dimensions of the broken drill bit was checked as far as possible and found to be in compliance with the technical drawings and ao/asif specification.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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Search Alerts/Recalls
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