Catalog Number 420915 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
Event Type
malfunction
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Event Description
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It was reported that the metal cutting slot on their femoral trumatch guide has been backing out as they cut through it.Additional event information: confirmed metal saw slot backed out on femoral guides from both patient cases.The saw slots backed out from press fit a small amount during cutting.Surgeon was utilizing a stryker straight blade.Thickness unknown.Surgeon was still able to make cuts and complete both cases without issue.
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Manufacturer Narrative
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Product complaint # (b)(4).Date of event is an unknown date.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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Additional information was received.Stating, that there was no surgical delay or any adverse outcome that occurred in 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.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: it was reported that the sales rep had a couple cases recently where the metal cutting slot on their femoral trumatch guide has been backing out as we cut through it.It has never happened before, but happened during our past 2 cases.The device associated with this report was not returned to depuy synthes for evaluation.The investigation could not confirm the reported event.A product development investigation was performed and it was concluded that the segmentation is designed within trumatch specifications and no issues were identified.A manufacturing record evaluation was performed for the finished device product description: trumatch ct cut guide kit l product code: 420915 lot number: tmk00069391 and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed for trumatch ct cut guide kit l.Based on the investigation findings, 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: a manufacturing record evaluation was performed for the finished device product description: trumatch ct cut guide kit l product code: 420915 lot number: tmk00069391 and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: trumatch ct cut guide kit l product code: 420915 lot number: tmk00069391 and no non-conformances or manufacturing irregularities were identified.
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Search Alerts/Recalls
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