Catalog Number 130738206 |
Device Problem
Difficult to Insert (1316)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/27/2020 |
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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Intraoperatively it had not been possible to insert the shoulder inlay stand.38/+3.Another inlay was used and procedure was completed successfully.
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Manufacturer Narrative
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Product complaint #l: (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.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (clinical and impact codes), h8.
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Event Description
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Additional information received indicated that there was a 4-minute surgical delay.
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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.Corrected: d3, g1, h3.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : examination of the returned device was not able to confirm the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
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Search Alerts/Recalls
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