WRIGHT MEDICAL TECHNOLOGY INC ALIGNMENT FRAME DIST SUB ASSEM INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33600020 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: slight scratches and blemishes can be seen around the instrument.No significant deformations are visible within the inner holes of the device.A pin sleeve with the same part number as the one referenced in the reported event was used to perform the functional test.The pin sleeve was able to fit through all six holes of the device.However, a 0.233 minus gage pin was used to verify the dimensions of the holes.The gage pin was unable to pass through all six holes of the device confirming the device was not manufactured to specification.Based in investigation, the root cause was attributed to a manufacturing related issue.A nonconformance was opened to further investigate the issue.
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Event Description
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It was reported that the sleeve did not pass through the guide arm.
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Search Alerts/Recalls
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