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

Model Number	FIBERTAG TIGHTROPE II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
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 10/06/2025, a distributor reported via email that an ar-1588rtt2 fibertag tightrope ii implant snapped at the button during final tensioning.No additional details were provided.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 10/08/2025: this occurred inside the patient during final tensioning.All fragments were retrieved from the surgical site.The case was completed using another ar-1588rtt2 fibertag tightrope ii implant, and the graft was re-stitched and implanted without issue.The procedure was delayed by approximately 30 minutes, but no additional anesthesia was administered.No adverse effects were reported.This event occurred during a quad tendon acl reconstruction procedure on (b)(6) 2025.
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 dfu for this device, dfu-0147-eo - g.Precautions - 1.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 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: FIBERTAG TIGHTROPE II
• 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: 23303302
• Report Number: 1220246-2025-04629
• Device Sequence Number: 15979377
• Product Code: MBI
• UDI-Device Identifier: 00888867426672
• UDI-Public: (01)00888867426672(11)250522(17)300430(10)15440368
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 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: FIBERTAG TIGHTROPE II
• Device Catalogue Number: AR-1588RTT2
• Device Lot Number: 15440368
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown