|
Model Number 24MM BASEPLATE, MONOBLOCK SCREW |
Device Problem
Fitting Problem (2183)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/30/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.
|
|
Event Description
|
It was reported on 12/30/2022 by a sales representative via email that an ar-9560-24s modular baseplate would not seat with the 15mm screw, surgeon opted to use the 25mm screw and was able to seat the baseplate to their satisfaction.Case involvement, no patient effect.
|
|
Search Alerts/Recalls
|
|
|