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	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 09-sep-2026, an arthrex subsidiary employee reported via email that an ar-1588btb-2j tightrope ii btb with deploying suture experienced an issue during an acl reconstruction using the btb technique performed on (b)(6)2026.While advancing the graft, it was not progressing properly through the tunnel.Evaluation at the tibial level revealed that the graft was trapped and not passing as intended.The implant was removed from the surgical field for inspection, at which time it was observed that one of the traction sutures was missing.A new implant was used, and upon reinsertion, the graft advanced properly through the tunnel.The procedure was completed successfully using an alternate implant.No additional anesthesia was administered.The patient outcome was not reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50868739
• Report Number: 1220246-2026-04865
• Device Sequence Number: 10674514
• Product Code: MBI
• UDI-Device Identifier: 00888867319660
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 09/23/2026

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: 15462879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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