MAUDE Adverse Event Report: ARTHREX, INC. MINI TIGHTROPE FT; WASHER, BOLT, NUT

Model Number	MINI TIGHTROPE FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
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 04-dec-2025, an arthrex subsidiary employee reported via email that the tip of the driver broke while inserting the screw of an ar-8917ds mini tightrope ft into an intermediate wedge-shaped bone hole.The screw was successfully placed, and all broken fragments were retrieved.The procedure was completed using a replacement ar-8917ds mini tightrope ft.The event occurred during a procedure on (b)(6) 2025.No detailed information was provided regarding the type of surgery.There was no significant delay, no additional anesthesia administered, and no adverse effects reported.No photos were taken.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8917ds batch 15464998 was received for investigation.Visual evaluation noted that the anchor was fractured.The device was returned without the sutures.Functional testing could not be performed due to the damage to the device.The most likely cause for the reported failure can be attributed to off-axis insertion, prying, and leveraging the device with excessive force.

• Brand Name: MINI TIGHTROPE FT
• Common Device Name: WASHER, BOLT, NUT
• 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: 23896121
• Report Number: 1220246-2025-05824
• Device Sequence Number: 14788470
• Product Code: HTN
• UDI-Device Identifier: 00888867048959
• UDI-Public: (01)00888867048959(11)250710(17)300630(10)15464998
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090107
• 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): 05/05/2026

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: MINI TIGHTROPE FT
• Device Catalogue Number: AR-8917DS
• Device Lot Number: 15464998
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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