Catalog Number 254500138 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
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 the tibial impactor, trial extractor and spacer block cracked.Unknown surgical delay.
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Event Description
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Additional information was received stating that there was no surgical delay or impact on the patient.
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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.D4 (expiration date) and h3.The expiration date (12/1/2099) in the initial medwatch was reported in error.The device involved was an instrument and does not have an expiration date.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: it was reported, that the tibial impactor, trial extractor and spacer block cracked.Unknown surgical delay.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 the attune tibial trial extractor has one of the prongs broken off.The broken fragment was not returned for evaluation.The observed, condition of the device was consistent with a component failure that was caused by exposure to unintended forces like usage of excessive force in a prying motion while trailing.The overall complaint was confirmed.As the observed, condition of the attune tibial trial extractor would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use error.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 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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