MAUDE Adverse Event Report: ARTHREX, INC. HTO ANCHOR, IBALANCE CORTICAL 48MM; BONE FIXATION PLATE

Model Number	HTO ANCHOR, IBALANCE CORTICAL 48MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/19/2025, a sales representative reported via (b)(4) that an ar-13402-48 hto anchor and an ar-13402-44 hto anchor broke.This occurred during a procedure when the anchors were broken at the shaft/screw head during insertion.Each anchor was prepped according to the technique guide, with the drill and tap steps completed.The surgery was completed with separate screws.No negative consequence to the patient.Additional information was provided on 06/24/2025, where the sales representative reported this event occurred during a high tibial osteotomy (ibalance hto), the screws broke during insertion into the tibia.The patient had good bone quality.The hto anchor drill and cortical tap were used to prepare the bone socket.All fragments were retrieved from the patient and another screw was used to complete the case.The case was delayed about 15 minutes with no additional anesthesia administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error of the device due to prying/leveraging, misalignment, and/or excessive force being used during insertion of the implant.

• Brand Name: HTO ANCHOR, IBALANCE CORTICAL 48MM
• Common Device Name: BONE FIXATION PLATE
• 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: 22510189
• Report Number: 1220246-2025-02884
• Device Sequence Number: 15639764
• Product Code: HRS
• UDI-Device Identifier: 00888867012189
• UDI-Public: (01)00888867012189(11)201019(17)250930(10)11930129
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K092381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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 Expiration Date: 09/30/2025
• Device Model Number: HTO ANCHOR, IBALANCE CORTICAL 48MM
• Device Catalogue Number: AR-13402-48
• Device Lot Number: 11930129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown