MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 2 8MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL UKA TIB BEA-RING TRL SZ 2 8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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 02/28/2025, it was reported by a sales representative via (b)(4) that an ar-601-tbb8 ibalance uka tibial bearing trial broke during trialing with the corner piece of the plastic sheared off and was successfully removed.No pieces broke off inside the patient.The case was completed successfully.This was discovered during a uka procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 03/07/2025: the case was completed using a back up tray.Another ar-601-tbb8 was used.There was no case delay or added anesthesia.No adverse effects on the patient reported.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.Visual inspection identified that one of the corners of the ibal uka tib bea-ring trl sz 2 || 8mm was broken, and the edges around the device were damaged.Functional testing was not performed due to the device's damage.The most likely cause can be attributed to damage incurred during the insertion and/or removal process of the device.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 2 8MM
• 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: 21620260
• Report Number: 1220246-2025-00987
• Device Sequence Number: 6687101
• Product Code: HWT
• UDI-Device Identifier: 00888867037502
• UDI-Public: (01)00888867037502(10)6791138
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/01/2025

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 2 8MM
• Device Catalogue Number: AR-601-TBB8
• Device Lot Number: 6791138
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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