SYNTHES MONUMENT 3.2MM DRILL BIT/QC/145MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH
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Catalog Number 310.310 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Patient age or date of birth and weight not available for reporting.Date of event: unknown.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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: it was reported, according to the technical assistant, the drill bit was not cutting.There was no patient harm.The drill will be replaced by a new one.This report is for one (1) 3.2mm drill bit.This is report 1 of 1 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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Additional information provided reveals procedure was completed successfully with no surgical delay.
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Search Alerts/Recalls
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