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 Codes	Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2025
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
On (b)(6) 2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1588tb-4 round, concave, ø 14 mm tightrope abs button could not be secured to the cortex when reinserting due to the patient's condition.A flat button was used to complete the case.This was discovered during use with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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 patient-specific factors, such as poor bone quality, which may prevent the button from achieving solid fixation, as the cortex may not provide adequate resistance for the button to lock against.Per dfu-0147-eo revision 5, c.Contraindications: 7.The use of this device may not be suitable for patients with insufficient or immature bone.The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature.

• 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: 23757687
• Report Number: 1220246-2025-05512
• Device Sequence Number: 10079408
• Product Code: MBI
• UDI-Device Identifier: 00888867157736
• UDI-Public: (01)00888867157736(11)210222(17)260131(10)12777439
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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 Expiration Date: 01/31/2026
• Device Model Number: TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE
• Device Catalogue Number: AR-1588TB-4
• Device Lot Number: 12777439
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown