MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAG TIGHTROPE II WITH INTERNALBRACE; NON-DEGRADABLE FIXATION 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	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/06/2025, a sales representative reported via email that an ar-1588rtt2-ib fibertag tightrope ii implant broke at the button during final femoral tensioning after the internalbrace was placed.The case was completed successfully, and no additional details were provided.This issue was discovered during a quad acl reconstruction procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 08/14/2025: the ib suture and the button of the ar-1588rtt2-ib fibertag tightrope ii implant were removed from the patient.To complete the case, an ar-1588btb-2j tightrope ii btb was utilized and threaded through the broken limb of the quadriceps tightrope.It was then shuttled into the fibertag loop while the graft remained positioned within both the femoral and tibial sockets.The procedure required an additional 20 minutes to complete, during which extra anesthesia was administered.A flipcutter was used to prepare the bone socket, and bone quality was assessed as normal.No adverse effects were reported during or following the surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 08/28/2025: the lot number for the ar-1588rtt2-ib fibertag tightrope ii used was lot 15428786.
Additional Manufacturer Narrative
Additional information: 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 excessive force being used when tensioning the sutures.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.

• Brand Name: FIBERTAG TIGHTROPE II WITH INTERNALBRACE
• Common Device Name: NON-DEGRADABLE FIXATION 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: 22895867
• Report Number: 1220246-2025-03634
• Device Sequence Number: 15666451
• Product Code: MBI
• UDI-Device Identifier: 00888867426689
• UDI-Public: 00888867426689
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 12/17/2025

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: 15428786
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 12/12/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/26/2025; 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown