Catalog Number 254400525 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that the femoral sizer was stiff.
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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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Additional information was received stating that it was discovered before surgery therefore there was no surgical delay.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: it was reported that the femoral sizer was stiff.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the attune mes sizing/rot gde [254400525/ab5149238].A functional test was performed, all components works as intended.The complaint condition was not able to be replicated.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was not confirmed as the attune mes sizing/rot gde [254400525/ab5149238] was found to have no damage or defects.No definitive root cause could be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There was no indication that a design or manufacturing issue contributed to the complaint.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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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