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

Model Number	TIGHTROPE® II ABS, IMPLANT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/21/2025
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 11/25/2025, an arthrex subsidiary employee reported via email that a knee arthroscopy with acl reconstruction performed on (b)(6) 2025 experienced multiple device issues.Two buttons, rtj 2 and abs 2, were initially prepared for an all-inside technique.During graft passage, the rtj 2 button became stuck in the tibial tunnel and broke, requiring removal.A btb 2-button was then opened, but its sutures appeared frayed and damaged despite being new.While assembling the graft and applying traction, the primary suture broke, compromising the graft.A third button, rtj 1, was used, and the graft was re-prepared.These issues caused delays that impacted case timing.The procedure was ultimately completed using an alternative device.Photos of the damaged sutures and broken loop were provided.
Event or Problem Description
Additional information was received on 12/29/2025: during the procedure, the rtj 2 button of the ar-1588tn-20 tightrope ii abs became stuck in the tibial tunnel.Following this issue, not all remaining tissue was removed from the patient.The abs 2 device was subsequently reused during graft preparation without complications; however, the part and lot number for abs 2 are unknown.Additionally, the btb 2-button of the ar-1588btb-2j was found frayed upon opening the package.The btb-2 button fractured when traction was applied to secure the graft during preparation on the back table.The surgeon completed graft fixation using a third button, rtj 1, without issues, though the part number for rtj 1 is unknown.The surgery was delayed by approximately 30¿45 minutes, but no additional anesthesia was administered.No adverse effects were reported during or after the procedure.A flipcutter iii was used to prepare the bone socket for implant insertion, and bone quality was assessed as good.
Additional Manufacturer Narrative
Additional information: b5, g3.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows the sutures were frayed/damaged.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 dfu-0147.G.Precautions - 1.Acl/pcl/btb/rt/abs tightrope only: excessive force on th 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 the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: TIGHTROPE® II ABS, IMPLANT
• 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: 23848185
• Report Number: 1220246-2025-05700
• Device Sequence Number: 13143503
• Product Code: MBI
• UDI-Device Identifier: 00888867371897
• UDI-Public: (01)00888867371897(11)250318(17)300228(10)15406293
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 03/27/2026

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® II ABS, IMPLANT
• Device Catalogue Number: AR-1588TN-20
• Device Lot Number: 15406293
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 03/26/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/19/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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