Catalog Number 254500726 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 11/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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Trial spring was damaged and femur trial was expired or ruptured.Products: fb insert test sz 6 and femoral test sz 6 ps.
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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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Event Description
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Additional information received indicated that the femoral test was cracked or broken and the inserted test spring was damaged during cleaning.There were no intraoperative complications or increased surgical time.
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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 for evaluation.Visual examination of the provided photograph found that the instrument was cracked.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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