Model Number 2163-11-004 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Code Available (3191)
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Event Date 09/08/2020 |
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 block was messed up and doesn¿t allow reamer to slide through either hole.
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Event Description
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Additional information received indicated that the case was delayed by about two minutes.
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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 hole damage which would restrict mating of a reamer.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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