MAUDE Adverse Event Report: ARTHREX, INC. K-LESS T-ROPE W/DRV, SYN REPR, SS; WASHER, BOLT, NUT

Model Number	K-LESS T-ROPE W/DRV, SYN REPR, SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 02-feb-2026, a sales representative reported via email that during a syndesmosis repair procedure on (b)(6) 2026, both an ar-8959tds syndesmosis tightrope xp buttress plate implant system and an ar-8925ss syndesmosis tightrope xp were inserted through the plate with the buttons flipped as intended.When the included tensioning handles were used, the sutures broke before adequate reduction could be achieved.The same issue occurred with both initial implants.The surgeon then opened two additional single-implant kits, and the suture breakage recurred with one of those implants as well.No patient harm was reported.Additional information was received on 05-feb-2026: on opening the ar-8959tds syndesmosis tightrope xp buttress plate implant system (lot: 15119012), the two included tightrope implants experienced suture breakage during tensioning.The facility then opened two ar-8925ss syndesmosis tightrope xp implants, and one of these (lot: 15292557) exhibited the same suture-fracture issue.The surgeon reported that the lateral round button was guided to the plate, and approximately two to three tensioning cycles were performed before the sutures fractured.Tensioning was applied along the implant, and no excessive force was noted.All detached sutures were retrieved, and all three constructs were removed and replaced.The case was completed using the 2-hole buttress plate from ar-8959tds and two additional ar-8925ss implants (lots: 15283929 and 15389071).No alternative fixation was attempted.The bone tunnel was created using the 3.7 mm drill bit provided in the kit.Bone quality was not assessed as poor.No patient adverse events were reported.The procedure was delayed by approximately one hour, and additional anesthesia was administered; however, the duration is unknown.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: K-LESS T-ROPE W/DRV, SYN REPR, 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: 24387324
• Report Number: 1220246-2026-00664
• Device Sequence Number: 18706633
• Product Code: HTN
• UDI-Device Identifier: 00888867281615
• UDI-Public: (01)00888867281615(11)240724(17)290630(10)15292557
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: K-LESS T-ROPE W/DRV, SYN REPR, SS
• Device Catalogue Number: AR-8925SS
• Device Lot Number: 15292557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2024
• 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