Catalog Number 227425800 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
No Information (3190)
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Event Date 09/07/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).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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Damaged instrument returned from the hospital.Wire covering coming off the drill shaft.This case has been reported by the loan kit technician during loan kit inspection.
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Manufacturer Narrative
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This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.
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Manufacturer Narrative
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Examination of the returned instrument confirmed the complaint.The root cause is attributed to wear out, high cycle fatigue fracture of the wire.The date code (b)(4) indicates the instrument was manufactured in april of 2005 and is over 11 years old.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.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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