Catalog Number 3335040 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Dmf# 13704, trade name: gentamicin sulphate, active ingredient(s): gentamicin sulphate, dosage form: powder, strength: 1.0g active in our cements.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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The gentamicin ampoule was found broken in the box.
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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).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 states that surgery's time wasn¿t extended.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: record shows the product associated with this report was delivered to the blackpool facility, however the product was not located for evaluation.The investigation could not draw any conclusions about the reported event without the product to examine.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 required.Device history lot: device history reviewed: 0 non-conformances on this lot number.Final micro and sterility tests passed.All qc release specifications met.(b)(4), units released.Lot expiry date: 28 february 2023.
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Search Alerts/Recalls
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