MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	ACL TIGHTROPE RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11th dec 2025, it was reported by an arthrex's employee via an email that for 2 unit of ar-1588rt, acl tightrope® rt, both units of the suture broke when retrieving.This was detected during an autologous tendon reconstruction of anterior cruciate ligament through knee arthroscopy surgery on (b)(6) 2025.The procedure was completed successfully by using another new one.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection of the white suture of the acl tightrope® rt, was broken off, and returned only half of the length.The button was not returned for investigation.Functional testing was not performed due to the damage to the device.Per dfu-0147-eo - tightrope devices.G.Precautions: 1.Acl/pcl/btb/rt/abs/cl/cls/pf/pfc tightrope only: excessive force on the shortening suture strands and/or tensioning the shortening suture strands not in-line with the bone socket may break the strands and impair the ability to fully seat the implant.No additional force on the shortening suture strands is required when the graft/wedge construct reaches the desired position in the femoral socket, and the graft stability is verified by pulling distally on the graft.The most likely cause of this failure is user error due to excessive force applied during suture tensioning and/or the device coming in contact with another device during use.

• Brand Name: ACL TIGHTROPE RT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 23934416
• Report Number: 1220246-2025-05924
• Device Sequence Number: 20236372
• Product Code: MBI
• UDI-Device Identifier: 00888867019553
• UDI-Public: (01)00888867019553(11)241209(17)291130(10)15358979
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: ACL TIGHTROPE RT
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 15358979
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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