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
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2022 |
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 mode.The device inspection revealed the following: slight scratches and blemishes can be seen within the inner holes of the instrument.However, no significant deformations are visible.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 could fit through all three distal holes of the instrument but could not pass through two of the proximal holes.A 0.233 minus gage pin was used to verify the dimensions of the holes.The gage pin could not fit through all six holes of the instrument confirming the device was not manufactured to specification.Based on 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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