MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE PFJ, BLADE STABILIZER SIZE 2; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE PFJ, BLADE STABILIZER SIZE 2
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via (b)(4) that an ar-602-21 ibalance pfj, blade stabilizer would not lock into the guide.The blade stabilizers' washer below the ball bearing seemed raised, prohibiting the instrument from engaging with the guide.This was discovered during the femoral finishing step of the pfj arthroplasty procedure with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 -complaint allegation is confirmed.-visual inspection noted that around the ball bearing of the cut stabilizer patellofemoral was damaged, the dowel pin had scratches/chipped, and the edges of the ibalance¿ pfj, blade stabilizer, size 2 were chipped.-functional testing was performed and noted that the ball bearing was stuck and did not work properly.The most likely cause of the reported failure can be attributed to wear and tear due to repeated use of the device in the field.Manufacturing date 2020.

• Brand Name: IBALANCE PFJ, BLADE STABILIZER SIZE 2
• 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: 23643950
• Report Number: 1220246-2025-05176
• Device Sequence Number: 13202666
• Product Code: LXH
• UDI-Device Identifier: 00888867038189
• UDI-Public: (01)00888867038189(11)200213(10)85712005
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/16/2025

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: IBALANCE PFJ, BLADE STABILIZER SIZE 2
• Device Catalogue Number: AR-602-21
• Device Lot Number: 85712005
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown