Model Number 2544-00-502 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 09/01/2020 |
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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Has product been potentially contaminated or is contaminated with bodily fluids? yes 2545-00-928 has a crack that was discovered during cleaning/steam sterilization.2545-01-969 has broken into 2 pieces that happened per-op.2544-00-502 a piece of plastic fell off during use per-operative.Where / when did the event occur? intra - op, post - op.What action was taken/required to manage the problem during the procedure? with same like product.
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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 the reported event.No evidence was found indicating product malfunction or product error as a contributing factor to the damage and the need for corrective action was not indicated.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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