MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS; NON-DEGRADABLE FIXATN FASTENER

Model Number	KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2025
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 6/18/2025, it was reported via email by a sales representative that an ar-2350 knotless tension tight button implant system experienced a failure.The tension tight button and suture both failed.The # 5 fiberlink was not locked at the swedge, allowing the suture to slide through itself rather than maintain tension.As the button was advanced past the swedge area, it continued to fail to hold tension.A new button was opened to complete the case, while the failed button remained implanted.This was discovered during a distal biceps repair procedure on (b)(6) 2025.Additional information was received on 06/27/2025: it is uncertain if the suture, the button, or both broke.It was confirmed that the whole system failed.The case was completed without issues using another ar-2350 knotless tensiontight button implant system.The case was delayed 15-20 minutes.It is uncertain if additional anesthesia was administered.
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 for the reported failure can be attributed to user error of the device due to excessive force used during suture pulling/tightening/tensioning.

• Brand Name: KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
• 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: 22508070
• Report Number: 1220246-2025-02872
• Device Sequence Number: 15616309
• Product Code: MBI
• UDI-Device Identifier: 00888867301924
• UDI-Public: (01)00888867301924(11)230412(17)280229(10)15080125
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K202444
• 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): 10/20/2025

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: KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
• Device Catalogue Number: AR-2350
• Device Lot Number: 15080125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown