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

Model Number	FIBERTAG TIGHTROPE II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
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 10-apr-2026, it was reported by a sales representative via phone that an ar-1588rtt2 fibertag tightrope's locking mechanism on the button broke when tensioning.No parts or fragments were identified when the issue occurred.The device was replaced with another ar-1588rtt2 tightrope to complete the case.The issue caused a 10-minute delay, in which the graft had to be removed and replaced.This occurred during use in an acl reconstruction case on (b)(6) 2026.There was no patient impact or additional anesthesia administered to the patient.

• Brand Name: FIBERTAG TIGHTROPE II
• 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: 25031955
• Report Number: 1220246-2026-02553
• Device Sequence Number: 16017570
• Product Code: MBI
• UDI-Device Identifier: 00888867426672
• UDI-Public: (01)00888867426672(11)250929(17)300831(10)15505509
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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
• Device Catalogue Number: AR-1588RTT2
• Device Lot Number: 15505509
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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