Model Number L94010 |
Device Problems
Failure to Cut (2587); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2021 |
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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Screw driver damaged, not gripping, edges with visible signs of wear.Calcar reamers not cutting, visible signs of wear.Was surgery delayed due to the reported event? yes.If yes, number of minutes: 10.Action taken when event occurred? another step of instruments opened.Was procedure successfully completed? yes.Were fragments generated? no.
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Manufacturer Narrative
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Product complaint # : (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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