Catalog Number 151620605 |
Device Problem
Wrong Label (4073)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/16/2024 |
Event Type
malfunction
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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 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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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Event Description
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It was reported that on apr.16, 2024, the color of the size indicator on the package of the product in question differed from the standard product version.(standard product: yellow, said product: pink).No further information is available.
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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.H10 additional narrative: added: d9.Corrected h3.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: it was reported that on apr.16, 2024, the color of the size indicator on the package of the product in question differed from the standard product version.(standard product: yellow, said product: pink).No further information is available.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the color indicator of the product on the package was pink instead of yellow.The reported allegation can be confirmed.A functional test was not performed as it is not applicable to the complaint condition.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune cr fb insrt sz 6 5mm would contribute to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: an nr was created to address current complaint condition.H10 additional narrative: corrected : h3.
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Search Alerts/Recalls
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