Model Number 2544-01-014 |
Device Problems
Break (1069); Device-Device Incompatibility (2919)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 08/24/2020 |
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 nipple on the shim side of the dog bone broke off.Without the nipple and the spring the shim will not stay connected to it.Even happened on the back table and both the plastic nipple and spring were located on the floor.No pieces landed in the patient.This did not delay surgery.
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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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The investigation findings did not indicate that a broader investigation or corrective action was necessary.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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