Model Number 2011-01-250 |
Device Problems
Break (1069); Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(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 noticed the problem on actis reamer stabilit and saw the risk of the broken reamer during surgery.Thickness of the reamer body seams are too weak even though no event happened.
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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.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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Search Alerts/Recalls
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