MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLES KIT FOR DX KNOTLESS FIBERTAK; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DISPOSABLES KIT FOR DX KNOTLESS FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
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, an arthrex subsidiary employee reported via email that an ar-8991ds disposables kit for dx knotless fibertak experienced drill root damage upon entering the bone while attached to a power tool.This resulted in fragments breaking off, and all fragments were then extracted.The procedure was completed using another ar-8991ds disposables kit for dx knotless fibertak, and no patient harm was reported.This was discovered during a procedure on (b)(6) 2025.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.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 was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion and/or prying/leveraging the device during use.
Event or Problem Description
Additional information received: this was discovered during an atfl repair procedure.The case was not delayed, and additional anesthesia was not needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.-complaint allegation is confirmed.-visual inspection of the disposables kit for dx knotless fibertak® , ve5, noted that the guidewire with ao for dx fibertak 1.8mm had broken off at quick-connect male fitting.-functional testing was not performed due to the damage to the device.The most likely cause is attributed to user error of the device due to over-torquing/over-engaging the guidewire within the power tool.

• Brand Name: DISPOSABLES KIT FOR DX KNOTLESS FIBERTAK
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 22080361
• Report Number: 1220246-2025-02194
• Device Sequence Number: 8397900
• Product Code: LXH
• UDI-Device Identifier: 00888867395954
• UDI-Public: (01)00888867395954(11)240925(17)290831(10)15322396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 12/24/2025

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: DISPOSABLES KIT FOR DX KNOTLESS FIBERTAK
• Device Catalogue Number: AR-8991DS
• Device Lot Number: 15322396
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 12/19/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 10/07/2025; 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown