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	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 19-jan-2026, it was reported by a sales representative via (b)(4) that an ar-611-7 ibal uka tibia trialing shim broke upon insertion.This was discovered during a uka, and the case was completed with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 -complaint allegation is confirmed.-visual inspection of one of the distal ends of the ibal uka, tibia trialing shim 2/3mm, was broken off.-functional testing was not performed due to the damage to the device.Dfu-0023-eo - e.Inspection and maintenance-1.Arthrex non-sterile devices are precision medical devices and must be used and handled with care.Inspect the devices for damage prior to use, and at all stages of handling thereafter.If damage is detected, do not use the device prior to consulting the manufacturer for guidance.The most likely cause of the reported failure can be attributed to wear and tear due to repeated use of the device in the field.Manufacturing date 2017.

• 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: 24291616
• Report Number: 1220246-2026-00471
• Device Sequence Number: 15785941
• Product Code: LXH
• UDI-Device Identifier: 00888867240346
• UDI-Public: (01)00888867240346(11)170516(10)051713
• 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): 03/16/2026

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: 051713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2017
• 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