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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 7th september 2026, it was reported by a distributor via an email that for 1 unit of ar-8979p, dx swivelock¿, 3.5 mm x 13.5 mm, it was unable to screw into the distal humerus bone during tommy john internal brace procedure.This was detected during an ucl internal brace procedure on (b)(6) 2026.The procedure was completed successfully by using additional ar-8979p.There was no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50841327
• Report Number: 1220246-2026-04833
• Device Sequence Number: 10461383
• Product Code: MBI
• UDI-Device Identifier: 00888867202900
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K150648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 15556340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2026
• 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