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 Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
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 07/23/2025, a sales representative reported via email that an ar-1588rtt2-ib fibertag tightrope ii implant had the tightrope break during basic passage.A replacement ar-1588rtt2-ib fibertag tightrope ii implant device was used to complete the case.This was discovered during a knee scope with acl procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 07/30/2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.Dfu-0147-eo: excessive force on the shortening suture strands and/or tensioning the shortening suture strands not in-line with the bone socket may break the strands and impair ability to fully seat the implant.No additional force on the shortening suture strands is required when the graft/wedge construct reaches the desired position in the femoral socket, and the graft stability is verified by pulling distally on the graft.The complaint allegation could not be confirmed as the device was not received for investigation.
Event or Problem Description
Additional information was received on 07/31/2025: the broken implant was retrieved from the patient.There was a 15-minute delay, with an additional 15 minutes of anesthesia administered to the patient.No adverse effects were reported on or after surgery.

• 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: 22771837
• Report Number: 1220246-2025-03400
• Device Sequence Number: 18477192
• Product Code: MBI
• UDI-Device Identifier: 00888867426689
• UDI-Public: (01)00888867426689(11)250128(17)291231(10)15379672
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/12/2025

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: 15379672
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown