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	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 11 sep 2026, it was reported by an arthrex employee via email that an ar-1588rt-j acl tightrope rt w/ deploying suture's suture failed.Upon inserting the graft and confirming the button flip, the itb was found to be protruding.An additional incision was made and pushed back into place using an instrument such as a pean clamp.Subsequently, the tensioning suture failed during the adjustment phase; however, since approximately 10 cm of the suture remained, adjustment was still possible the procedure was completed successfully using the same product.No patient harm was reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50898732
• Report Number: 1220246-2026-04905
• Device Sequence Number: 5829463
• Product Code: MBI
• UDI-Device Identifier: 00888867095533
• UDI-Public: (01)00888867095533(11)260610(17)310531(10)15637655
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/25/2026

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: ACL TIGHTROPE RT W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-J
• Device Lot Number: 15637655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2026
• 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