MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 3 8MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL UKA TIB BEA-RING TRL SZ 3 8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
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 12/11/2024, it was reported by a sales representative via (b)(4) that an ar-601-tbc8 ibalance uka, tibial bearing trial, size 3, 8 mm fell apart with pieces found and removed with no further information provided.The patient was not affected.This was discovered during a procedure, with no reported patient harm.Additional information was received on 12/17/2024: this was discovered during use on 12/09/2024.The poly broke, pulling it out of the patient.Both pieces were easily taken out of the patient.This issue did not delay the case.There was no adverse reaction to the case or the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged, ar-601-tbc8, ibalance¿ uka, tibial bearing trial, size 3, 8 mm, batch: 5261608, was received for investigation.Visual inspection identified that the tibial bearing trial had fragmented, with dents around the trial body.No fragments were received for evaluation.Dimensions were not measured, and functional testing was not performed due to the damaged condition of the device.The most likely cause for the reported failure can be attributed to wear and tear.The manufacturing date is 2016.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 3 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: 21113201
• Report Number: 1220246-2025-09307
• Device Sequence Number: 7474205
• Product Code: HWT
• UDI-Device Identifier: 00888867037564
• UDI-Public: (01)00888867037564(11)160308(10)5261608
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/29/2025

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 3 8MM
• Device Catalogue Number: AR-601-TBC8
• Device Lot Number: 5261608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2016
• 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