MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS 3 HOLE BUTTON 11MM CONCAVE; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE ABS 3 HOLE BUTTON 11MM CONCAVE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
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
On 12/30/2024 it was reported by a sales representative via (b)(4) that an ar-1588tnt2 fibertag tightrope and an ar-1588tb-3ib tightrope abs tensioning strands broke at the button.This was discovered during the case.The case was delayed 30 minutes and another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, including excessive force shortening suture strands and/or tensioning the shortening suture strands not in-line with the bone socket may break the strands.The complaint allegation was not confirmed, and no evidence of the failure was received.

• Brand Name: TIGHTROPE ABS 3 HOLE BUTTON 11MM 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: 21217529
• Report Number: 1220246-2025-00048
• Device Sequence Number: 12958365
• Product Code: MBI
• UDI-Device Identifier: 00888867395374
• UDI-Public: 00888867395374
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 09/04/2025

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: TIGHTROPE ABS 3 HOLE BUTTON 11MM CONCAVE
• Device Catalogue Number: AR-1588TB-3IB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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