Catalog Number 227425500 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/17/2016 |
Event Type
malfunction
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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.(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Event Description
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Drill bit broke roughly 10 - 15mm distal of the tip while drilling dome screws.
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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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Manufacturer Narrative
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Examination of the returned drill confirmed the complaint; the majority of the fluted tip broke off.A complaint database search has identified a trend for this failure within the 2274 quickset drill family.Previous investigations have determined that use error is the likely root cause.As a result of trending health hazard evaluation, dva-106292-hhe was conducted.The investigation did not establish the need for corrective action.No evidence was found of product or design error as a contributing factor.Complaints will be monitored under sep 419 post market surveillance.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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