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

Model Number	TIGHTROPE ABS, 14 MM BUTTON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 20-jan-2026, a sales representative reported that an ar-1588tb-1 tightrope abs button snapped in half while cycling the knee during an arthroscopic acl reconstruction.The broken piece was removed from the patient without issue, and another button was used to complete the procedure.No patient harm was reported.Additional information was received on 23-jan-2026: the button was fully seated within the tightrope loop before the break occurred.Another ar-1588tb-1 device was used to complete the procedure.The surgery was not delayed, no additional anesthesia was administered, and no adverse patient effects were reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: TIGHTROPE ABS, 14 MM BUTTON
• 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: 24294495
• Report Number: 1220246-2026-00483
• Device Sequence Number: 9408224
• Product Code: MBI
• UDI-Device Identifier: 00888867019638
• UDI-Public: (01)00888867019638(11)250904(17)300831(10)15493225
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/27/2026

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, 14 MM BUTTON
• Device Catalogue Number: AR-1588TB-1
• Device Lot Number: 15493225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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