MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS T-ROPE SYN-DESMOSIS REPR TI; WASHER, BOLT, NUT

Model Number	KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
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 10/15/2025, an arthrex subsidiary employee reported via email that an ar-8926t knotless tightrope syndesmosis repair implant broke when traction was applied during injury reduction.As a result, a second device was required to complete the procedure.All broken pieces were retrieved from the patient.This occurred during an open reduction and internal fixation (orif) of ankle syndesmosis performed on (b)(6) 2025.Additional information has been requested on 10/20/2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically improper bone preparation, excessive force, and/or incorrect surgical technique.The complaint allegation was confirmed following evaluation of the attached customer-provided image, which showed that the sutures were broken and frayed.A suture bunch was also observed, which may indicate improper surgical technique.
Event or Problem Description
Additional information: the case was completed using another ar-8926t knotless tightrope syndesmosis repair implant.The event occurred during the insertion process, prior to the implant being fully placed or traction being applied.The surgery was not delayed, and no additional anesthesia was administered to the patient.All detached fragments, including buttons and sutures, were accounted for and retrieved during the procedure.No adverse effects were reported during or following the procedure as a result of this issue.

• Brand Name: KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
• Common Device Name: WASHER, BOLT, NUT
• 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: 23377740
• Report Number: 1220246-2025-04796
• Device Sequence Number: 8823893
• Product Code: HTN
• UDI-Device Identifier: 00888867049086
• UDI-Public: (01)00888867049086(11)250101(17)291231(10)32461
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K043248
• 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): 02/27/2026

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: KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
• Device Catalogue Number: AR-8926T
• Device Lot Number: 32461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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