MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 5/9/2024, a sales representative reported via (b)(4) that an ar-8978p dx swivelock sl with a forked eyelet anchor had the fork tip break off, and the screws would not release from the metal tip of the mechanism.This was discovered during a procedure.Additional information has been requested.Additional information was received on 5/20/2024: this was discovered during a ucl hand procedure on (b)(6) 2024.All broken pieces were retrieved from the patient.There was no case delay.The case was completed by opening another anchor.It is unknown if the patient experienced adverse effects due to the issue.
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 can be attributed to misaligned insertion; or prying/leveraging the device during use.

• Brand Name: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• 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: 19489739
• Report Number: 1220246-2024-05166
• Device Sequence Number: 12518656
• Product Code: MBI
• UDI-Device Identifier: 00888867193925
• UDI-Public: 00888867193925
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Report Date (Section B): 04/03/2025

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 SL, 3.5X8.5MM W/FORK EYELET
• Device Catalogue Number: AR-8978P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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