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 02/24/2023 |
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 mode.The device inspection revealed the following: the middle distal hole of the instrument can be seen to be deformed.Aside from this deformation, no other significant damages can be found around the instrument.Two pin sleeves were returned and used to perform the functional test.The pin sleeves could not fit through the three distal holes but were able to pass through the three proximal holes of the instrument.A 0.233 minus gage pin was used to verify the dimensions of the holes.The gage pin was unable to fit through all six holes of the instrument confirming the instrument was not manufactured to specification.Based on investigation, the root cause was attributed to a manufacturing related issue.A nonconformance was opened to further address the issue.
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Event Description
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It was reported that the pin could not be inserted into the center hold of the alignment frame guide.Medical procedure was completed by pushing pin sleeve to end of hole.
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Search Alerts/Recalls
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