MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS BUTTON ROUND 20MM CONCAVE; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE ABS BUTTON ROUND 20MM CONCAVE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/03/2025, a sales representative reported via phone that an ar-1588tnt2 fibertag® tightrope® ii abs implant, and an ar-1588tb-5 tightrope® abs button broke.This occurred during a quad tendon acl reconstruction on (b)(6) 2025.When the surgeon began tensioning the ar-1588tnt2 broke resulting in the ar-1588tb-5 button breaking and falling out to the floor.All fragments were recovered from the patient.The patient had a good bone quality, and it was uncertain if anything was used to prepare the bone.There was a delay of about 30 minutes that required additional anesthesia for that time.The procedure was completed using another ar-1588tnt2 fibertag® tightrope® ii abs implant, and another ar-1588tb-5 tightrope® abs button.There was no harm on the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such excessive force during the tightening process and misaligned insertion or improper bone preparation.

• Brand Name: TIGHTROPE ABS BUTTON ROUND 20MM 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: 23618572
• Report Number: 1220246-2025-05134
• Device Sequence Number: 8977934
• Product Code: MBI
• UDI-Device Identifier: 00888867240582
• UDI-Public: (01)00888867240582(11)231110(17)281031(10)15166038
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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 20MM CONCAVE
• Device Catalogue Number: AR-1588TB-5
• Device Lot Number: 15166038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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