Model Number 1100-50-000 |
Device Problems
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 06/10/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that the customer received a delivery where the plastic wrapping of the product box was loose and somehow damaged, the customer did not dare to use it because it can be non-sterile now.
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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: the product was returned to depuy synthes and sent to depuy cork manufacturing site.Depuy cork team conducted a visual inspection of the returned device and confirmed the reported allegation of loose wrap.However the sterility of the device was not compromised.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 : a manufacturing record evaluation was performed for the finished device lot: 3794638 (p/n: 110050000) and no non-conformances or manufacturing irregularities related to the malfunction were identified.Device history review : a manufacturing record evaluation was performed for the finished device lot: 3794638 (p/n: 110050000) and no non-conformances or manufacturing irregularities related to the malfunction were identified.
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Search Alerts/Recalls
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