Model Number 420915 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
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Event Description
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It was reported that the instrument was no fit properly.The issue was occurred on (b)(6) 2023.Surgeon had to trip off osteophytes for the guide to still not fit properly.It was not able to key the guide in on the anterior flange.A few minute surgical delay to play around with guide.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence was not able to observe defects or signs of a product malfunction.The investigation could not confirm the reported event.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: tmk00045840 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: tmk00045840 and no non-conformances or manufacturing irregularities were identified.
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Event Description
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Additional information received.A.Was there a surgical delay? if yes, what is the duration of the delay? -1 minute to adjust the guide.B.Was there any impact on the patient? if yes, please clarify in detail.-no pt impact.
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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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Search Alerts/Recalls
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