MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE® II ABS, IMPLANT OPEN; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE® II ABS, IMPLANT OPEN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via e-mail that an ar-1588btb¿2j btb tightrope while pulling the blue tab the metal wire broke not fully engaging the suture back through itself and through the button and an ar-1588tn-21 tightrope the sutures that is wrapped around in the back of the card was fully extended and would not level/even out with the loaded suture.This occurred during a pcl procedure cause a delay of about 10-15 minutes.
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.
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 pre-mature tensioning of the device.

• Brand Name: TIGHTROPE® II ABS, IMPLANT OPEN
• 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: 19463853
• Report Number: 1220246-2024-04891
• Device Sequence Number: 7870853
• Product Code: MBI
• UDI-Device Identifier: 00888867371903
• UDI-Public: 00888867371903
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• 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): 05/21/2025

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: TIGHTROPE® II ABS, IMPLANT OPEN
• Device Catalogue Number: AR-1588TN-21
• Device Lot Number: 15212283
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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