SYNTHES SELZACH 1.5MM DRILL BIT/STRYKER J-LTCH WITH 6MM STOP/44.5MM; DRILL, BONE, POWERED
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Catalog Number 317.660 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/10/2014 |
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 not detected any fragment inside of the patient and also not observed fragments outside.The breakage did not interfere with surgery; the drill was replaced and the procedure was continued.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Additional product codes: erl, hbe.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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Device was used for treatment, not diagnosis.Additional narrative: no nonconformance reports 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.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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