Model Number 1516-40-506 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2021 |
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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Surgeon said the attune insert would not lock into place for some reason.Seems everything was clear of debris, when they opened a second insert the fit was fine.So this is a report about the first insert they tried to use.
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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 for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : device history record (dhr) reviewed, no deviations or non-conformances were noted.
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Search Alerts/Recalls
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