WRIGHT MEDICAL TECHNOLOGY INC INBONE¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 200009902 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device has not returned for evaluation.If additional information becomes available, it will be provided on a supplemental report.
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Event Description
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It was reported that the base plate has no plasma spray.
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Manufacturer Narrative
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The reported event could be confirmed, since images were provided that confirm the part/lot on the label and packaging.Although no images or confirmation of the actual device were provided, there are other complaints that confirm the issue.Based on investigation, the root cause was attributed to manufacturing related issue.The failure was caused by a vendor not applying the plasma coating as intended and an inspector failing to identify this issue at incoming inspection.A non conformance report has been initiated to address this event a further investigate the problem.
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Event Description
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It was reported that the base plate has no plasma spray.
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Search Alerts/Recalls
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