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

Model Number	ACL TIGHTROPE RT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 28th july 2025, it was reported by an arthrex's employee via email that for 1 unit of ar-1588rt, acl tightrope® rt, the implant cannot be deploy.This was detected during an anterior cruciate ligament reconstruction of the knee joint on (b)(6) 2025.The case was completed successfully by using another ar-1588rt.There was no patient harm.Additional information: this case reported by hospital as ae.
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 device was not received for evaluation.Based on the information provided which may include the 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 used during suture passing/tightening/tensioning and/or shortening the strands not in-line with the bone socket.The dfu for tightrope® devices, dfu-0147-eo revision 3, gives the following 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.2.Load the acl/pcl tightrope button over the unspliced, thinner portion of the acl/pcl tightrope suture to assist assembly.Once assembled slide the acl/pcl tightrope button down to the thicker, spliced portion of the acl/pcl tightrope suture to help prevent disassembly.

• Brand Name: ACL TIGHTROPE RT
• 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: 22774904
• Report Number: 1220246-2025-03415
• Device Sequence Number: 18538085
• Product Code: MBI
• UDI-Device Identifier: 00888867019553
• UDI-Public: (01)00888867019553(11)240429(17)290331(10)15241431
• 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): 09/16/2025

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
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 15241431
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown