Catalog Number 399.560 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/01/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This report is for an unknown chisel blade/unknown lot.Device is an instrument and is not implanted/explanted.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Event Description
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Device report from synthes europe reports an event in (b)(6) as follows: the screw head broke while using the screwdriver to turn it to lock the chisel blades.There was a surgery prolongation of twenty (20) minutes.This report is for an unknown chisel blade.This is report 4 of 4 for (b)(4).
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Manufacturer Narrative
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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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Event Description
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Patient condition reported as fine.This is report 3 of 3 for (b)(4).
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Search Alerts/Recalls
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