MAUDE Adverse Event Report: ARTHREX, INC. DX KNOTLESS SWIVELOCK, BC, 4.75 MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	DX KNOTLESS SWIVELOCK, BC, 4.75 MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Additional 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, improper bone preparation and/or excessive force used when tensioning the sutures.
Event or Problem Description
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.

• Brand Name: DX KNOTLESS SWIVELOCK, BC, 4.75 MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19080693
• Report Number: 1220246-2024-01943
• Device Sequence Number: 6030429
• Product Code: MAI
• UDI-Device Identifier: 00888867319868
• UDI-Public: 00888867319868
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: DX KNOTLESS SWIVELOCK, BC, 4.75 MM
• Device Catalogue Number: AR-8980BC
• Device Lot Number: 13355439
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown