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Model Number 24MM BASEPLATE, MODULAR |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.Visual evaluation, the edges of the hex tip had damage.Functional testing identified that the returned device did not work as required.The probable cause of this condition can be that the hex tip must be aligned between the components in order for the taper to engage and rotate the components until the hex features align, resulting in a tactile coupling and were not engaged properly.The most likely cause is attributed to misuse due to user error.
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Event Description
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It was reported that during a univers revers mgs surgery screw which is pressed into the plate did not hold.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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Search Alerts/Recalls
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