Catalog Number 254500995 |
Device Problem
Component Missing (2306)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (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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These items were reported by (b)(6) csd staff.Not related to an operative case.Attune liner trial is missing an o-ring spring.
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Manufacturer Narrative
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(b)(4).Investigation summary the device associated with this report was not returned to depuy in warsaw for evaluation.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Manufacturer Narrative
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Product complaint # (b)(4) investigation summary: the device associated with this report was not returned to depuy in warsaw for evaluation.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.10 october 2018 re-open upon receipt of the device examination of the returned device confirms the reported event.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.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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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: the device associated with this report was not returned to depuy in warsaw for evaluation.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.10 october 2018 re-open upon receipt of the device examination of the returned device confirms the reported event.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.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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Search Alerts/Recalls
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