MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA, TIBIA TRIALING SHIM 2/3MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	IBAL UKA, TIBIA TRIALING SHIM 2/3MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-611-7 serial/batch number (b)(6) was received for investigation.No functional testing was performed due to the damage to the device.A visual inspection revealed that the device's tip was broken off and not returned.The most likely cause of the reported failure is the instrument's wear and tear from repetitive use and reprocessing.The device's manufacturing date is 06-apr-2021.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 14-apr-2026, it was reported by a sales representative via (b)(4) that an ar-611-7 tibial trialing shim broke off on one side during a case.Noticed during a case but able to be completed with no patient effect.

• Brand Name: IBAL UKA, TIBIA TRIALING SHIM 2/3MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 25045803
• Report Number: 1220246-2026-02581
• Device Sequence Number: 13193138
• Product Code: LXH
• UDI-Device Identifier: 00888867240346
• UDI-Public: (01)00888867240346(11)210406(10)052107
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/22/2026

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, TIBIA TRIALING SHIM 2/3MM
• Device Catalogue Number: AR-611-7
• Device Lot Number: 052107
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown