MAUDE Adverse Event Report: ARTHREX, INC. MINI TIGHTROPE FT; WASHER, BOLT, NUT

Model Number	MINI TIGHTROPE FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
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 (b)(6) 2024, an arthrex subsidiary employee reported via email that an ar-8917ds mini tightrope ft thread broke when trying to suture.The case was completed using another mini tightrope ft.This was discovered during a procedure on (b)(6) 2024.There was no harm to the patient.Requested additional information.Additional information received on 12/20/2024: this was discovered during a lisfranc procedure.The case was not delayed, and additional anesthesia was not needed.
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: MINI TIGHTROPE FT
• 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: 21125137
• Report Number: 1220246-2025-09349
• Device Sequence Number: 7583419
• Product Code: HTN
• UDI-Device Identifier: 00888867048959
• UDI-Public: (01)00888867048959(11)240409(17)290331(10)15232032
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090107
• 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): 07/11/2025

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: MINI TIGHTROPE FT
• Device Catalogue Number: AR-8917DS
• Device Lot Number: 15232032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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