Catalog Number 254500366 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2023 |
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 the holder device was locked closed and would not open.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: it was reported, that the holder device was locked closed and would not open.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed, that attune femoral trial gripper was found with the inner mechanism stuck.And its unable to be opened.The allegation can be confirmed.No other defect was found.The femoral trial gripper should not be used to fully seat the trials, as the prongs protrude past the distal surface of the trial.The femoral trial gripper can be used for sizes 3 - 10 only.When extracting the trial, rocking it medio-laterally may cause condylar fracture.Such rocking should be avoided.A dimensional inspection was performed.For the attune femoral trial gripper was not performed, as it is not applicable to the complaint condition.The overall complaint was confirmed.As the observed, condition of the attune femoral trial gripper would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error.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 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, 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).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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Search Alerts/Recalls
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