MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ® II RT WITH DEPLOYING SUTURE; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE ® II RT WITH DEPLOYING SUTURE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic evidence of a frayed/separated ar-1588rt-2j tightrope ® batch 15506184.Based on the information provided which may include the returned device (if available), photographs, videos, event description, and any additional field input arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as excessive force applied during use.
Event or Problem Description
It was reported that during an anterior cruciate ligament reconstruction surgery the suture of the device failed.The failure occurred at a critical moment of the operation, which exposed the patient to an extended procedure time and the need to use an additional implant.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: TIGHTROPE ® II RT WITH DEPLOYING SUTURE
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 24885965
• Report Number: 1220246-2026-02226
• Device Sequence Number: 10564777
• Product Code: MBI
• UDI-Device Identifier: 00888867319714
• UDI-Public: (01)00888867319714(11)250929(17)300831(10)15506184
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K241235
• 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): 04/15/2026

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 ® II RT WITH DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-2J
• Device Lot Number: 15506184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2025
• 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
• Patient Sex: Unknown