Catalog Number 254400525 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/20/2024 |
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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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 the sizer dial was broke in half.
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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: it was reported, that the sizer dial was broke in half.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device found, that the attune mes sizing/rot gde was broken off from the center rod.The broken fragment was not returned for evaluation.The observed, condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Due to the low frequency of this occurrences and not suspecting any design issue, a definitive root cause cannot be established.The overall complaint was confirmed.As the observed, condition of the attune mes sizing/rot gde would have contributed to the device issue.Based on the investigation findings, the potential cause is not established.And 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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