MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA, FEMORAL IMPACTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL UKA, FEMORAL IMPACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
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 09-jan-2026, it was reported by a sales representative via (b)(4) that an ar-611-6 ibal uka femoral impactor tip broke off.This was discovered during the case.Another device was used to complete the case with no patient harm.

• Brand Name: IBAL UKA, FEMORAL IMPACTOR
• 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: 24177771
• Report Number: 1220246-2026-00311
• Device Sequence Number: 9524647
• Product Code: LXH
• UDI-Device Identifier: 00888867223875
• UDI-Public: (01)00888867223875(11)160215(10)37621552
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: IBAL UKA, FEMORAL IMPACTOR
• Device Catalogue Number: AR-611-6
• Device Lot Number: 37621552
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown