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

Model Number	KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
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 31-dec-2025, it was reported by an arthrex employee via (b)(4) that (qty.2) of an ar-8926ss knotless t-rope experienced a malfunction.When the doctor pulled the sutures one by one to close the syndesmosis, the tightrope sutures broke; another tightrope was provided to perform the repair, and when the sutures were pulled again, they broke.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
• 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: 24079282
• Report Number: 1220246-2026-00218
• Device Sequence Number: 5878962
• Product Code: HTN
• UDI-Device Identifier: 00888867049079
• UDI-Public: (01)00888867049079(11)250201(17)300131(10)32758
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 05/13/2026

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: KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
• Device Catalogue Number: AR-8926SS
• Device Lot Number: 32758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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