Model Number 2545-00-708 |
Device Problems
Material Discolored (1170); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).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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(b)(6) informed there is damage to some of the attune cr trial instruments that are on consignment.They have also noticed some of the coloured markings are coming off during the sterilisation process - the markings were found in the bottom of the tray.They have asked for a complete replacement of one of these trays on consignment.No patient consequence.Further information provided that trials are scratched and gauged.
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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 : examination of the returned device confirmed minor nicks and scratches on the anterior flanged portion of trial.The noted minor damage is consistent with normal intended use and the investigation did not establish a need for corrective action.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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