Catalog Number 254500138 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2024 |
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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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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During the surgery, when the specialist was preparing to remove the test insert from the tibia with the extractor piece, it split in one of its corners.The piece was removed with its fragment and could be handled without any problems.There was no delay in the surgery or consequence to the patient.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary according to the information received, "during the surgery, when the specialist was preparing to remove the test insert from the tibia with the extractor piece, it split in one of its corners.The piece was removed with its fragment and could be handled without any problems." the product was not returned to depuy synthes, however photos were provided for review.See attachment ¿source file - reporte de calidad en la clinica los farallones-cali colectivo 474788¿.The photo investigation revealed that '254500138, attune tibial trial extractor¿ had broken off.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.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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