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

Model Number	ACL TIGHTROPE
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl surgery the suture tore during tightening.The torn device was fixed with a screw.Per complaint reporter there was no harm for patient, operator or third party.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 confirmed.-upon visual inspection, it was noted that the white suture returned was broken off and frayed at one end of the suture and around the holes of the oblong button.Blue suture was not returned.-functional testing was not performed due to the damage to the device.Per the surgical technique, the sutures should be tensioned perpendicular to the button face.The sutures will break when pulled against the edge of the hole in the button (not perpendicular).Eco-37907 was implemented to improve the design of the button to reduce these failures due to misuse.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
• 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: 22576136
• Report Number: 1220246-2025-03025
• Device Sequence Number: 9699986
• Product Code: MBI
• UDI-Device Identifier: 00888867019614
• UDI-Public: (01)00888867019614(11)241209(17)291130(10)15359083
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 15359083
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown