MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT W/ DEPLOYING SUTURE; SMOOTH FIXATION PIN

Model Number	ACL TIGHTROPE RT W/ DEPLOYING SUTURE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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 11th august 2025, it was reported by an arthrex's employee via email that for 1 unit of ar-1588rt, acl tightrope® rt, the white suture could not be pull out.This was detected during a tendon reconstruction surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-1588rt.There was no patient harm, and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: b5, d1, d2b, d4, d9, g3, g4, h3, h6.-complaint allegation is confirmed.-visual evaluation revealed that the suture system was damaged; the loops were damaged, which shows a frayed white section of the suture with bunching.No visual issues were found with the button, the blue and white/black sutures.-functional testing was not performed due to the damage to the device.Per dfu-0147-eor3_fmt_en tightrope® devices g.Precautions 1.Acl/pcl/btb/rt/abs tightrope only: 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 most likely cause can be attributed to user error, as excessive force on the shortening suture strands may break the strands and impair the ability to fully seat the implant.
Event or Problem Description
Additional information received on 27th nov 2025: it was ar-1588rt-j, acl tightrope® rt, double loaded passing sutures, not ar-1588rt.

• Brand Name: ACL TIGHTROPE RT W/ DEPLOYING SUTURE
• Common Device Name: SMOOTH FIXATION PIN
• 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: 22907110
• Report Number: 1220246-2025-03670
• Device Sequence Number: 8093639
• Product Code: MBI
• UDI-Device Identifier: 00888867095533
• UDI-Public: (01)00888867095533(11)230629(17)280531(10)15110421
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: ACL TIGHTROPE RT W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-J
• Device Lot Number: 15110421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 08/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown