MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE® II RT, RECON IB¿; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE® II RT, RECON IB¿
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 29th october 2025, it was reported by an arthrex employee via email that for an ar-1588rt-ib, tightrope® ii rt, reconstruction with internalbrace¿ ligament augmentation repair, it failed at the sheath.This was detected during an acl reconstruction on (b)(6) 2025.The procedure was completed successfully as btb tightropes (ar-1588btb-ib) was used.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic evidence showing damage to an ar-1588rt-ib tightrope®, batch 15432395.Based on the available information ¿ including photographic evidence and the event description ¿ arthrex has determined the most likely cause of the reported issue.The most likely contributing factors include user-related factors such as: off-axis insertion improper bone preparation over-tensioning during implantation.

• Brand Name: TIGHTROPE® II RT, RECON IB¿
• 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: 23450851
• Report Number: 1220246-2025-04950
• Device Sequence Number: 8961103
• Product Code: MBI
• UDI-Device Identifier: 00888867291638
• UDI-Public: (01)00888867291638(11)250507(17)300430(10)15432395
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/05/2026

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, RECON IB¿
• Device Catalogue Number: AR-1588RT-IB
• Device Lot Number: 15432395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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