Model Number 2546-00-418 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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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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Surgeon performing revision knee with attune revision system.Following reaming of tibial im canal and preparation of proximal tibia with sequential broaches the below broaches become stuck/wedged into the tibia and whilst surgeon attempted to extract the broach with the broach handles the couplings on the handles which attach to the broaches were disengaging with heavy mallet blows.Successfully extracted the broach using adaptor trial extractor (threaded into broach female recess).This was cross-threaded and now stuck in the size 45 tibial broach (surgeon aware this instrument not designed for broach extraction but remained the only option to attempt extraction of the tibial broach.Surgery completed successfully.No further information required.No further info available.
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Manufacturer Narrative
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Product complaint # : pc-(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 was unable to confirm the reported event.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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