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

Model Number	IBAL UKA, TIBIAL IMPACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
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 06/02/2025, it was reported by a distributor via (b)(4) that an ar-611-4 tibial impactor broke upon impact.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged, ar-611-4, batch 052204, was received for investigation.Visual evaluation found that the impactor head is broken off.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to wear and tear.Due to continuous mechanical forces applied to it, the device will inevitably sustain damage over time.The device's manufacturing date was 2022.Refer to the investigation photos.The complaint allegation is confirmed.

• Brand Name: IBAL UKA, TIBIAL 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: 22336516
• Report Number: 1220246-2025-02652
• Device Sequence Number: 9172193
• Product Code: LXH
• UDI-Device Identifier: 00888867223868
• UDI-Public: (01)00888867223868(11)220526(10)052204
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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, TIBIAL IMPACTOR
• Device Catalogue Number: AR-611-4
• Device Lot Number: 052204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 05/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown