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	Failure of Implant (1924)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by an arthrex subsidiary employee via email that an ar-8980bc dx knotless swivelock, an ar-8913ds mini tightrope, and an ar-7237-7 fibertape could not be easily implanted.The patient's bone was hard, so the surgeon tapped the implants in with a mallet to place them in the tunnel.This was discovered during a lisfranc procedure on (b)(6) 2024.One to two weeks later, on (b)(6) 2024, the patient underwent revision surgery to have all the products explanted.The ar-8980bc dx knotless swivelock anchor had pulled out of the medial cuneiform bone.The lisfranc ligament plasty procedure was completed using an ar-8913ds mini tightrope from lot number 15242118, an ar-7237-7 fibertape from lot number 15081694, and an ar-8922 suture button from lot number 15166049.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation.

• 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: 20268246
• Report Number: 1220246-2024-07778
• Device Sequence Number: 7315821
• Product Code: MAI
• UDI-Device Identifier: 00888867319868
• UDI-Public: 00888867319868
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: DX KNOTLESS SWIVELOCK, BC, 4.75 MM
• Device Catalogue Number: AR-8980BC
• Device Lot Number: 15050278
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown