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	04/09/2025
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 04/16/2025, it was reported by a sales representative via email that an ar-1588rtt2-ib fibertag tightrope ii implant for the internal brace technique broke during basic passage.A new tightrope was opened, and the case was completed.No patient was harmed.This was discovered during a knee scope with acl procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested if this occurred before use on the back table.
Event or Problem Description
Additional information has been received on 05/13/2025: this issue occurred during graft passage; all pieces were retrieved from the patient.The case was completed with another ar-1588rtt2-ib fibertag tightrope ii implant.A delay of approximately 20 minutes was reported, and additional anesthesia was administered accordingly.No adverse effects or significant damage were reported.No photos were taken.
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 excessive user-applied mechanical forces.

• 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: 22005208
• Report Number: 1220246-2025-02005
• Device Sequence Number: 12539866
• Product Code: MBI
• UDI-Device Identifier: 00888867426689
• UDI-Public: (01)00888867426689(11)241212(17)291130(10)15360874
• 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): 09/24/2025

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: 15360874
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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