MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during the anterior cruciate ligament surgery, the button of the tightrope malfunctioned.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
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.-visual evaluation revealed that the tightrope® abs, button, round, concave, ø 14 mm, was scratched/damaged.-functional testing was not performed due to the damage to the device.Per surgical technique - lt1-000228 - technique: fixation over full tunnels - 1 - after passing the graft transtibially, attach the tightrope abs button to the proximal abs loop by inserting each side into its respective slot and pulling the button down to the spliced area where it will be locked onto the loop (1a).If using backup sutures, place them through the additional holes in the button.Pull the tightrope abs implant tensioning strands to advance the button to bone.Ensure the collar of the button enters the tunnel and the button is lying on the cortex(1b) - 2 final graft tension may now be set by pulling on the tensioning strands of the tightrope® implant.Cycle the knee and re-tension the implant as desired.Cut the tensioning strands flush.Alternatively, the tensioning sutures of the tibial tightrope ii abs implant can be tied over the abs button for additional fixation.-3 final fixation.The most likely cause of the reported failure can be attributed to improper surgical technique and/or the device coming in contact with another device during use due to surface damage.

• Brand Name: TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 23818559
• Report Number: 1220246-2025-05639
• Device Sequence Number: 9396259
• Product Code: MBI
• UDI-Device Identifier: 00888867157736
• UDI-Public: (01)00888867157736(11)250502(17)300430(10)15430176
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 02/11/2026

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: TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE
• Device Catalogue Number: AR-1588TB-4
• Device Lot Number: 15430176
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• 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