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Model Number SUTR ANCH,PEEK SWI-VELOCK,3.5X 15.8MM |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/22/2021 |
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error due to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
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Event Description
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It was reported that during an ankle internal brace procedure, the ar-2325pslc and the ar-8990, pulled out due to the bone quality and location.No additional information provided.Additional information requested.
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Search Alerts/Recalls
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