Catalog Number UNK FIXATION PIN |
Device Problems
Device-Device Incompatibility (2919); Mechanical Jam (2983)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 09/03/2020 |
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 got stuck in a pin hole during the procedure, and could not be removed.Had to cut both ends of the pin off, and leave the rest of it stuck in the block in order to proceed.No surgical delay.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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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