Catalog Number 254500920 |
Device Problems
Crack (1135); Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/05/2024 |
Event Type
malfunction
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Event Description
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It was reported that the shims were cracked/missing metal connecting pieces.
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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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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, that 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: according to the information received, it was reported that the shims were cracked/missing metal connecting pieces.Patellar clamp is sticking/ not functioning properly.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that there was no damage or defects with the attune conv shim.Based on the drawing specifications, a new design solution was developed for the device attune conv shim and the solution involves now it is going to be a single piece/all plastic part, thus get rid of the metal bushing.The overall complaint was unconfirmed as the observed condition of the attune conv shim would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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