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

Model Number	FIBERTAG TIGHTROPE II WITH INTERNALBRACE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
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 04/23/2025, a sales representative reported via phone that an ar-1588rtt2-ib fibertag tightrope ii implant and an ar-1288rtt2-fc fibertag tightrope ii broke during the tensioning process at the cortical button.Everything was removed from the patient.The case was completed using an ar-1288qis-100 quadlink implant system.The case had a delay of more than one hour but less than two hours.It is unknown the amount of added anesthesia administered to the patient.No adverse effects were reported on or after the surgery.This was discovered during a primary acl reconstruction procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error.This includes pulling the sutures close to a rough bone.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: FIBERTAG TIGHTROPE II WITH INTERNALBRACE
• 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: 21961602
• Report Number: 1220246-2025-01891
• Device Sequence Number: 17969584
• Product Code: MBI
• UDI-Device Identifier: 00888867426689
• UDI-Public: (01)00888867426689(11)241216(17)291130(10)15362394
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 10/02/2025

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 WITH INTERNALBRACE
• Device Catalogue Number: AR-1588RTT2-IB
• Device Lot Number: 15362394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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