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	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/18/2024, a sales representative reported via (b)(4) that an ar-8925ss knotless tightrope had an issue during a procedure.The tightrope was implanted well but when the tension was applied the button of the medial malleolus went through the fracture inside the bone, and the doctor had to bite the suture to remove it.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a 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: 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: 20600127
• Report Number: 1220246-2024-08385
• Device Sequence Number: 21068739
• Product Code: HTN
• UDI-Device Identifier: 00888867281615
• UDI-Public: (01)00888867281615(11)240130(17)281231(10)15200429
• Combination Product (Y/N): N
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: 15200429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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