Catalog Number 254500565 |
Device Problem
Component Missing (2306)
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Patient Problem
No Information (3190)
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Event Date 09/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this 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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Missing balseal.Update 05 oct 2016 - we received info that the missing balseal is not in patient's body.
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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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Additional narrative: examination of the returned devices confirms the reported event of a missing balseals.Hhe/qrb (quality review board) (b)(4) recommended a device correction which was initiated on june 12, 2015.Capa-(b)(4) determined the likely root cause to be related to misuse, and requires mandatory sales training on proper use and application of the device by depuy sales consultants.Capa-(b)(4) will also monitor the mandatory field training.The need for further corrective action was not indicated.Continue to monitor disassociation events per post market surveillance (b)(4).Depuy considers the investigation closed at this time.Should the 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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