MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE PFJ BLADE KIT, SIZE 3; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE PFJ BLADE KIT, SIZE 3
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/11/2024, it was reported by a sales representative via (b)(4) that an ar-602-28 ibalance¿ pfj blade kit fractured the left femoral condyle while prepping the femur with a blade kit during a case.The case was completed successfully, and no further information was provided.No pieces broke inside the patient reported.This was discovered during a pfj procedure on (b)(6) 2024.Additional information was received on 11/14/2024: the rep stated that the condyle fractured while the surgeon impacted the proximal blade and used the standard surgical technique indicated.After the fracture, a non-arthrex headless screw was used to stabilize the fracture, and an arthrex ibalance pfj system completed the case while using the standard technique.There was a 10-minute delay while they waited for the non-arthrex product to be received.No x-rays are available of the patient.No medical intervention or hospitalization was needed for the patient, and no additional surgery was required.
Additional Manufacturer Narrative
Additional information: 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 due to user-applied excessive mechanical forces.

• Brand Name: IBALANCE PFJ BLADE KIT, SIZE 3
• 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: 20865443
• Report Number: 1220246-2024-08745
• Device Sequence Number: 8831055
• Product Code: GFA
• UDI-Device Identifier: 00888867038257
• UDI-Public: (01)00888867038257(11)221108(17)271031(10)15020981
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 07/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IBALANCE PFJ BLADE KIT, SIZE 3
• Device Catalogue Number: AR-602-28
• Device Lot Number: 15020981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown