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

Model Number	ACL TIGHTROPE
Medical Device Problem Codes	Failure to Advance (2524); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the device became blocked inside the joint and then the pull in suture tore.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different 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.One unpackaged ar-1588t, acl tightrope®, batch number 15378964, was received for investigation.Visual inspection noted that the suture system was returned disassembled.Additionally, the white sutures were torn.Functional testing was not performed due to the damage to the device.The method used to prepare the bone, as well as the bone quality encountered during the procedure, were not provided.The most likely cause can be attributed to improper bone preparation; misaligned insertion; or prying/leveraging the device during use.Refer to the investigation photos.Complaint allegation is confirmed.

• Brand Name: ACL TIGHTROPE
• 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: 22787354
• Report Number: 1220246-2025-03445
• Device Sequence Number: 12798184
• Product Code: MBI
• UDI-Device Identifier: 00888867019614
• UDI-Public: (01)00888867019614(11)250127(17)291231(10)15378964
• 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,Company Representative
• 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
• Device Catalogue Number: AR-1588T
• Device Lot Number: 15378964
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown