Catalog Number 3095040 |
Device Problems
Device Damaged Prior to Use (2284); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Dmf# - (b(4), trade name gentamicin sulphate, active ingredient(s) gentamicin sulphate, dosage form - powder strength 1.0g active in our cements.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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It was reported that the inner packaging seal was connected to the outer package seal.This meant when the product was opened, sterility was compromised.As a result a second cement needed to be opened.
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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 was received and stated that there was no delay to the surgery.There was a delay to the set up of about 5 minutes.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned item found the inner packaging seal was connected to the outer package seal.The reported complaint condition was able to be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the depuy nonconformance (nc) quality system found one nc¿s associated with this product/lot combination.
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Search Alerts/Recalls
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