Model Number 2545-00-564 |
Device Problems
Device-Device Incompatibility (2919); Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problem
No Code Available (3191)
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Event Date 06/02/2020 |
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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Attune cr tray would not accept spacer.Spring or bushing is damaged.
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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.H6 patient code: no code available (3191) used to capture prolonged surgery and insufficient information.Corrected: h6 device code- damaged - unspecified is being retracted as additional information indicates spring was deformed.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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Event Description
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It was stated that there was a surgery delay of 3 minutes.
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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.
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Search Alerts/Recalls
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