Catalog Number 254400521 |
Device Problems
Break (1069); Loose or Intermittent Connection (1371); Device Slipped (1584)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/22/2020 |
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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It was reported that the pin grommet in the femoral jig came loose.All pieces were recovered, and we need to replace the jig.No surgical delay.
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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.
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Event Description
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Additional information received stated that the metal pin grommet broke off the guide into 2 pieces.The pieces were recovered.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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