MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 1 9MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL UKA TIB BEA-RING TRL SZ 1 9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
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 08/12/2025, it was reported by a sales representative via (b)(4) that an ar-611-4 ibal uka tibial impactor tip was broken and an ar-601-tba9 ibal uka tib bea-ring was broken.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-601-tba9 batch 6791420 was received for evaluation.Visual inspection revealed that the device shows cracks in the material.Nicks, gouges, and deformation were also noted.A functional test cannot be performed as the device is damaged.The most likely cause of the reported failure is damage incurred over repetitive usage.Device manufacturing date 2014.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 1 9MM
• 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: 22902585
• Report Number: 1220246-2025-03659
• Device Sequence Number: 18125873
• Product Code: HWT
• UDI-Device Identifier: 00888867037458
• UDI-Public: (01)00888867037458(11)140522(10)6791420
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/05/2025

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: IBAL UKA TIB BEA-RING TRL SZ 1 9MM
• Device Catalogue Number: AR-601-TBA9
• Device Lot Number: 6791420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown