Model Number 9505-02-055 |
Device Problems
Break (1069); Component Missing (2306)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/26/2020 |
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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It was reported that the spring button on keel punch impactor broke off during surgery.Two pieces, spring and button broke off.No surgical delay.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : examination of the returned device could not confirm the reported breakage, but could confirm missing components.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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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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