MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAG TIGHTROPE II ABS; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAG TIGHTROPE II ABS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2025
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 18th december 2025, it was reported by an arthrex employee via email that for an ar-1588tnt2, fibertag® tightrope® ii abs implant, the needle on the tightrope broke off the suture when the surgeon was whipstitching graft.This was detected during an acl reconstruction on (b)(6) 2025.The procedure was completed successfully as a new tightrope was opened and the procedure continued.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 user-related, such as excessive force during the tightening process.

• Brand Name: FIBERTAG TIGHTROPE II ABS
• 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: 23978094
• Report Number: 1220246-2026-00083
• Device Sequence Number: 4578691
• Product Code: MBI
• UDI-Device Identifier: 00888867426696
• UDI-Public: (01)00888867426696(11)250121(17)291231(10)15375805
• 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): 04/22/2026

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: FIBERTAG TIGHTROPE II ABS
• Device Catalogue Number: AR-1588TNT2
• Device Lot Number: 15375805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown