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	06/11/2024
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 06/13/2024 it was reported by an arthrex subsidiary employee via e-mail that an ar-8917ds 3.5 mm mini tightrope¿ ft broke at the button.This occurred during a case on a lisfranc joint of a foot.The technique went without any problems, but when a surgeon tightened the final tension, the fw broke at the button.He removed the button and screw.Additional information received on 6/20/2024: all the broken fragments were removed from the patient.After the ar-8917ds 3.5 mm mini tightrope failed, the surgeon did not use additional products, as it was determined that the fixing force was sufficient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 or the device coming in contact with another device during use.

• 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: 19700037
• Report Number: 1220246-2024-06651
• Device Sequence Number: 7674126
• Product Code: HTN
• UDI-Device Identifier: 00888867048959
• UDI-Public: 00888867048959
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: 15180875
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown