MAUDE Adverse Event Report: Arthrex, Inc. K-LESS T-ROPE W/DRV, SYN REPR, TI; WASHER, BOLT, NUT

Model Number	K-LESS T-ROPE W/DRV, SYN REPR, TI
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information was received on 21-sep-2026:\ the tightrope xp implant system was fully implanted before the issue was identified.Following deployment, the button position was confirmed after placement.During adjustment of the button, it penetrated the second cortical bone.No damage, deformation, breakage, fraying, or other visible abnormalities were observed on the device components.\ \ the affected implant was completely removed, and no device fragments were generated or retained in the patient.The procedure was prolonged by approximately one hour due to the event, resulting in approximately one additional hour of anesthesia administration.Alternative fixation was achieved using hardware from another manufacturer.\ \ the patient's bone quality was reported as good.The hospital stay was not extended, and no additional treatment, monitoring, or follow-up related to the event has been reported.No patient injury or adverse outcome was reported.Information regarding the patient's postoperative status and outcome is not available.\ \ additional information was received on 24-sep-2026:\ this was discovered during an ankle and syndesmosis arthroscopy procedure.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6\ \ 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, TI
• Common Device Name: WASHER, BOLT, NUT
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50828460
• Report Number: 1220246-2026-04821
• Device Sequence Number: 10590563
• Product Code: HTN
• UDI-Device Identifier: 00888867281608
• UDI-Public: (01)00888867281608(11)250820(17)300731(10)15485545
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: K-LESS T-ROPE W/DRV, SYN REPR, TI
• Device Catalogue Number: AR-8925T
• Device Lot Number: 15485545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown