MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE SYNDESMOSIS REPAIR CANNULATED; WASHER, BOLT, NUT

Model Number	TIGHTROPE SYNDESMOSIS REPAIR CANNULATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/26/2024, an arthrex representative reported via (b)(4) that an ar-8920cds tightrope had an issue in a case.The tightrope was not compressing with the loop.The device presented problems in its reduction, causing its wires to break.The reduction of its components was not behaving as expected.The surgeon used another device to finish the procedure.There was no patient harm or injury.
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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: TIGHTROPE SYNDESMOSIS REPAIR CANNULATED
• 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: 20224215
• Report Number: 1220246-2024-07645
• Device Sequence Number: 11639170
• Product Code: HTN
• UDI-Device Identifier: 00888867048980
• UDI-Public: 00888867048980
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 06/18/2025

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: TIGHTROPE SYNDESMOSIS REPAIR CANNULATED
• Device Catalogue Number: AR-8920CDS
• Device Lot Number: 29209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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