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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl surgery, the button did not flip and the device did not hold.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 confirmed.Upon visual inspection, it was identified that the white suture returned was damaged.The button was returned.The blue and white/black sutures were not returned.Functional testing was not performed due to damage to the device.Per surgical technique acl tighrope #2 pass the blue passing suture, white flipping suture, and white tensioning strands together through the femur.Use the blue passing suture to advance the button, while keeping tension on the white tensioning strands to prevent slack from forming and bunching up in the tunnel.Pull the button through the femur and confirm the button is flipped with the white flipping suture.A line on the implant marked at the intraosseous length is helpful to signal that the button has exited the femur.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 W/ DEPLOYING SUTURE
• 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: 21858139
• Report Number: 1220246-2025-01526
• Device Sequence Number: 15425961
• Product Code: MBI
• UDI-Device Identifier: 00888867095533
• UDI-Public: (01)00888867095533(11)241126(17)291031(10)15353559
• 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): 07/18/2025

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 W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-J
• Device Lot Number: 15353559
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown