Model Number 2055-13-000 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Customer is not able to clean the instrument behind spring balls.No adverse patient impact, no surgical delay.
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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: the device associated with this report was returned for analysis.Visual examination of the part did not exhibit foreign substances which could affect functionality and/or appearance.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: quantity manufactured: (b)(4) pcs.Date of manufacture: 5/9/2022.Any anomalies or deviations identified in dhr: 1 qhf was found for uniform finish on top of post.Expiry date: n/a.Ifu reference: 090200836 rev.H.Device history review: a manufacturing record evaluation was performed for the finished device (205513000/pg319561) product and lot numbers, and no non-conformances were identified.Corrected: h3, h4.
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Search Alerts/Recalls
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