Catalog Number 254500566 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/19/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Examination of the returned device confirms the reported event.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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It was reported that the attune insert trial broke during trialing process, needs to be replaced.The surgeon tried to use a mallet to reduce the insert trial on the tray, so the product breaking was not a result of being defective.No surgical delay.No broken pieces of instrumentation left in patient.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: examination of the returned device confirms the reported event.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 # = > pc-(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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Search Alerts/Recalls
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