MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE, SOFT BUTTON, FIBERTAG, IB; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE, SOFT BUTTON, FIBERTAG, IB
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2025
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 10/7/2025, it was reported by a sales representative via email that an ar-1588sbr-rtt-ib tightrope, soft button, fibertag, ib all-suture tightrope button with internal brace did not bunch properly outside the lateral cortex of the femur.As a result, the implant was replaced with a metal button.This issue was identified during an acl reconstruction procedure performed on (b)(6) 2025.The original implant was cut out and discarded.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 -complaint allegation is not confirmed.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.Per surgical technique guide - lt1-000317 - all-suture button graft passing technique - 01 for proper deployment, the button should be oriented with only the blue passing suture and white tensioning strands toward the femur for shuttling, leaving behind the fibertape® and tigerwire® sutures in line with the graft.02 - pass the blue passing suture and white tensioning strands together through the femur.Keep the white-and-black tigerwire suture under tension to elongate the button (a).With equal tension, pull the blue passing suture and white tensioning strands together to advance the button through the lateral cortex.Pull on the inside of the tibial-sided tightrope® or the fibertape suture to deploy the soft-button anchor.Marking the intraosseous length on the implant may be helpful to signal that the button has exited the femur.The button can also be viewed through the medial portal as it exits the femoral cortex.The most likely cause of the reported failure can be attributed to user error of the device due to incorrect surgical technique during the mechanism process, excessive force used during suture passing/tightening/tensioning the device.

• Brand Name: TIGHTROPE, SOFT BUTTON, FIBERTAG, IB
• 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: 23335527
• Report Number: 1220246-2025-04690
• Device Sequence Number: 13404967
• Product Code: MBI
• UDI-Device Identifier: 00888867501324
• UDI-Public: (01)00888867501324(11)250530(17)300430(10)15444440
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K250424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: TIGHTROPE, SOFT BUTTON, FIBERTAG, IB
• Device Catalogue Number: AR-1588SBR-RTT-IB
• Device Lot Number: 15444440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown