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

Model Number	ACL TIGHTROPE RT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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 07/05/2025, a distributor reported via email that an ar-1588rt acl tightrope rt had a blocked implant during use.There was no report of breakage during this procedure.The case was completed with another product; no further details were provided.This was discovered during an lca procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 07/11/2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is not confirmed.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.According to dfu-0147.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 the 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 of the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• 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: 22674677
• Report Number: 1220246-2025-03162
• Device Sequence Number: 7486987
• Product Code: MBI
• UDI-Device Identifier: 00888867019553
• UDI-Public: (01)00888867019553(11)250113(17)291231(10)15371948
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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): 10/16/2025

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: 15371948
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown