MAUDE Adverse Event Report: ARTHREX, INC. ACL FIBERTAG® TIGHTROPE® IMPLANT SYSTEM; NON-DEGRADABLE FIXATN FASTENER

Model Number	ACL FIBERTAG® TIGHTROPE® IMPLANT SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
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 09/24/2024, it was reported by a sales representative via email that the harvester from an ar-1288qt-100 acl fibertag tightrope implant system broke while initiating the graft harvest.All the broken fragments were removed, and the case was completed using an ar-2386-10 quadpro harvester.The case was delayed about thirty seconds and no additional anesthesia was needed.The patient was not affected.This was discovered during a quad auto acl reconstruction procedure on (b)(6) 2024.
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 being used during insertion of the implant.

• Brand Name: ACL FIBERTAG® TIGHTROPE® IMPLANT SYSTEM
• 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: 20353418
• Report Number: 1220246-2024-07939
• Device Sequence Number: 15082433
• Product Code: MBI
• UDI-Device Identifier: 00888867344716
• UDI-Public: (01)00888867344716(11)210802(17)250930(10)13846866
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/08/2025

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 Expiration Date: 09/30/2025
• Device Model Number: ACL FIBERTAG® TIGHTROPE® IMPLANT SYSTEM
• Device Catalogue Number: AR-1288QT-100
• Device Lot Number: 13846866
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2021
• 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