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

Model Number	ACL TIGHTROPE RT
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament repair surgery it was noticed that the tightrope was incorrectly assembled and no extension of the loop was possible.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.Upon visual inspection, it was noted that the loop of the acl tightrope® rt was damaged.Functional testing was performed, and the loop was extended as required.No problem found.

• 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: 23083902
• Report Number: 1220246-2025-03909
• Device Sequence Number: 14648995
• Product Code: MBI
• UDI-Device Identifier: 00888867019553
• UDI-Public: (01)00888867019553(11)250220(17)300131(10)15392927
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: 15392927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 08/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown