Catalog Number 270904100 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/26/2022 |
Event Type
malfunction
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Event Description
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It was reported that the black plastic covering on the metal inside of the tray had peeled during the washing process.
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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.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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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: visual examination of the returned device confirmed, the reported allegation.The investigation found the black plastic inside the delivery system peeling off.Additionally, some of the black retention pins and corner tabs are deformed/bent and one of the side silver locking pins is missing.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: 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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