Catalog Number 254401014 |
Device Problems
Detachment of Device or Device Component (2907); Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2023 |
Event Type
malfunction
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Event Description
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It was also discovered that the springs were loose on the spacer block and they fell off.No adverse effects, no time added to surgery.
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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 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 there is a giant crack in the femoral trial.The crack is located near the box.The instrument did not break into two pieces.No adverse effects.No time added to surgery.It was also discovered that the springs were loose on the spacer block and they fell off.They were thrown in the trash can.No adverse effects.No time added to surgery.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed that two springs of the attune spacer block were missing, this missing condition typically occurs when the springs are damaged, causing them to deform or break.Therefore, the feel apart and loose conditions can be confirmed.The observed condition of the device was consistent with use of excessive force in prying motion while trailing.Properly handling and attention to the approved use of the device diminishes the rick for this type of failure.The overall complaint was confirmed as the observed condition of the attune spacer block would contribute to the complaint device issue.Based on the investigation finding, the potential cause is traced to unintended user error.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As a 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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