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Model Number DX KNOTLESS SWIVELOCK, BC, 4.75 MM |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/27/2022 |
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 due to misaligned insertion, improper bone preparation and/or excessive force used when tensioning the sutures.
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Event Description
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On (b)(6) 2022, it was reported by a sales representative via email that an ar-8980bc dx knotless swivelock anchor slid into the shaft and pulled out when shaft was removed from the patient.Surgeon tapped again and used an ar-2324pslc peek-swivelock, which the anchor also slid into the driver shaft and pulled out when it was removed.Finally, an ar-1540ps peek tenodesis screw was used to complete the case.This was discovered during a patella tendon repair procedure on (b)(6) 2022.
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Search Alerts/Recalls
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