MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ® II BTB WITH DEPLOYING SUTURE; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE ® II BTB WITH DEPLOYING SUTURE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a distributor reported via email that three tightrope devices, ar-1588rt-2j tightrope ii rt and two ar-1588btb-2j tightrope ii btb, were involved in issues during a hamstring lca reconstruction procedure on (b)(6) 2025.An ar-1588rt-2j tightrope ii rt (lot 15412617) and an ar-1588btb-2j tightrope ii btb (lot 15446881) experienced knotless mechanism failure during graft insertion into a 4 mm femoral tunnel, preventing completion of the primary function despite following the recommended technique and without excessive force.The third device, ar-1588btb-2j tightrope ii btb (lot 15462879), experienced a suture jam in the knotless mechanism during conversion step 3 of the btb tightrope technique.The straight limb suture (2) became stuck, preventing system conversion.Additional information was received on 12/01/2025: for the ar-1588rt-2j tightrope ii rt (lot 15412617) and the ar-1588btb-2j tightrope ii btb (lot 15446881), the failure occurred after the button was flipped while pulling the white sutures to bring the graft into the tunnel.The final tension has not yet been achieved.For the third device, ar-1588btb-2j tightrope ii btb (lot 15462879), the straight limb suture was found to be frayed when it became jammed (see attached photos).The case was completed using ar-1588tb-4 tightrope abs.A button was used over the femoral cortex, and the surgeon made knots because there was no more btb onsite.The case was delayed 30 to 45 minutes.It is unknown where additional anesthesia was administered.All detached fragments were accounted for.A 4mm drill pin and an 8mm pilot head reamer for the femur, as well as a 2.4 mm drill pin and an 8mm cannulated drill for the tibia, were used to prepare the bone socket for implantation.The bone quality was normal.No adverse effects were reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of a torn ar-1588rt-2j batch 15446881.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as increased friction on the white pull sutures or jamming of the knotless mechanism.

• Brand Name: TIGHTROPE ® II BTB WITH DEPLOYING SUTURE
• 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: 23777592
• Report Number: 1220246-2025-05585
• Device Sequence Number: 15973445
• Product Code: MBI
• UDI-Device Identifier: 00888867319660
• UDI-Public: (01)00888867319660(11)250605(17)300531(10)15446881
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: TIGHTROPE ® II BTB WITH DEPLOYING SUTURE
• Device Catalogue Number: AR-1588BTB-2J
• Device Lot Number: 15446881
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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