Catalog Number 483136920 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2024 |
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 surgeon complained about heads shedding and wanted to replace those with the new style.
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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.Corrected: d4 (lot), d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: it was reported, that surgeon complained about heads shedding and wanted to replace those with the new style.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed, that there were no damage or defect with the dps trl hd m 36 -2.A dimensional inspection was performed and met specifications.A functional test was unable to be performed, due to mating device not returned.The complaint condition was not able to be replicated.The overall complaint was unconfirmed.As the observed, condition of the dps trl hd m 36 -2, 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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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.Corrected: d1, d2a, d3, d4 (catalog, primary udi number), g1.
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Search Alerts/Recalls
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