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Model Number TITANIUM SWIVELOCK, 4.75X19.1MM |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2022 |
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 most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, prying/leveraging the device and/or excessive force being used during insertion of the implant.
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Event Description
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It was reported on (b)(6) 2022 by a facility representative via email that an ar-2324slm suture anchor suture broke.This was discovered during case with no patient harm.Per facility: "the sutures are betrayed gently, and at the moment of fixing the anchors, one of the sutures is cut (it breaks)".
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Search Alerts/Recalls
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