Model Number 2178-63-180 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Code Available (3191)
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Event Date 11/04/2020 |
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 distal femoral jig would not slide over the 20 mm revision reamer.We tried all the other reamers and they worked so it has to be the 20 mm revision reamer.A surgical delay of five minutes.
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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 event mating issue, however, examination of the device found areas of wear and deformation on the corners of the flats.The investigation attributed the root cause to normal use and servicing and did not establish 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 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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