Catalog Number 3095040 |
Device Problems
Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385); 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 01/09/2024 |
Event Type
malfunction
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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 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that the packaging was damaged which lead to liquid leaking form the bottle, in resulted that this item unable to use.Was surgery delayed due to the reported event? no.Was procedure successfully completed? yes.
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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 that 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.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: according to the information received, bottle packaging damaged which lead to liquid leaking form the bottle, in resulted that this item unable to use.The product was not returned to depuy synthes, however photos were provided for review.See attachment img_3765.Jpeg, img_3770.Jpeg, img_3769.Jpeg, img_3765.Jpeg, img_3764.Jpeg.The photo investigation revealed that smartset ghv gentamicin 40g was observed that the amber vial is damage, which could have caused the liquid to spill within the same packaging.This type of damage is attributed to transport/storage of the device.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces during the transport/storage process.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the smartset ghv gentamicin 40g would contribute to the complained device issue.Based on the investigation findings it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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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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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Sterility compromised : yes as the package was leak (please see the attached photos).
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Search Alerts/Recalls
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