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

Model Number	TIGHTROPE ® II BTB WITH DEPLOYING SUTURE
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2025
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 2nd february 2026, it was reported by an arthrex employee via email that for an ar-1588btb-2j, tightrope® ii btb, with deploying suture, the white tightrope suture was not shuttling through the rt button.The sutures were extremely frayed and made passing very difficult.This was detected during an unspecified procedure on (b)(6) 2025.The procedure was completed successfully as a new unit was opened.

• Brand Name: TIGHTROPE ® II BTB 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: 24232991
• Report Number: 1220246-2026-00346
• Device Sequence Number: 21399922
• Product Code: MBI
• UDI-Device Identifier: 00888867319660
• UDI-Public: (01)00888867319660(11)250527(17)300430(10)15442101
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 05/27/2026

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 BTB WITH DEPLOYING SUTURE
• Device Catalogue Number: AR-1588BTB-2J
• Device Lot Number: 15442101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2025
• 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