MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK, 3.5 X 13.5 MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX SWIVELOCK, 3.5 X 13.5 MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/3/2024, it was reported by a sales representative via email that an ar-8979p dx swivelock anchor was stuck to the shaft and could not be inserted.This was discovered during a tendon repair procedure on (b)(6) 2024.The case was completed using a new anchor.Attempting to remove the anchor from the shaft delayed the case for fifteen to twenty minutes.
Event or Problem Description
Additional information received on 10/7/2024: additional anesthesia was not needed for the delay in the case.The case was completed using a new ar-8979p dx swivelock.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 can be attributed to misaligned insertion; or prying/leveraging the device during use.

• Brand Name: DX SWIVELOCK, 3.5 X 13.5 MM
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 20428293
• Report Number: 1220246-2024-08105
• Device Sequence Number: 18039805
• Product Code: MBI
• UDI-Device Identifier: 00888867202900
• UDI-Public: (01)00888867202900(11)230823(17)280731(10)15132628
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150648
• 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,Followup,Followup
• Report Date (Section B): 09/10/2025

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 Model Number: DX SWIVELOCK, 3.5 X 13.5 MM
• Device Catalogue Number: AR-8979P
• Device Lot Number: 15132628
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 09/03/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 10/16/2024; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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
• Patient Sex: Unknown