MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS MINI TR IMPLANT, 2.7MM, TI; WASHER, BOLT, NUT

Model Number	KNOTLESS MINI TR IMPLANT, 2.7MM, TI
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 05-mar-2026, a sales representative reported via email that an ar-8908ds knotless mini tightrope implant system had the suture not tension normally.This was discovered during a lisfranc orif procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 11-mar-2026: the problem was identified inside the patient when the tightrope device was tightened.As tension was applied, the device bunched up on one of the strands, resulting in uneven tension and preventing the construct from fully tightening.The suture became damaged as a direct result of the issue.The affected implant was removed, and the case was completed using a second ar-8908ds device.The event caused only a brief delay of a few minutes, and no additional anesthesia was administered.No adverse patient effects were reported during or following the procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: KNOTLESS MINI TR IMPLANT, 2.7MM, 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: 24689668
• Report Number: 1220246-2026-01651
• Device Sequence Number: 15953703
• Product Code: HTN
• UDI-Device Identifier: 00888867351578
• UDI-Public: (01)00888867351578(11)240909(17)290831(10)15314344
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K213644
• 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): 07/08/2026

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 MINI TR IMPLANT, 2.7MM, TI
• Device Catalogue Number: AR-8908DS
• Device Lot Number: 15314344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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