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	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/18/2024, a sales representative reported via sems-(b)(4) that an ar-611-7 ibalance uka tibial trialing shim was broken while testing the leg in flexion.All fragments were retrieved from the patient.There was no case delay.The case was completed with the surgeon tensioning the knee with "feel" instead of a 2mm stick.There were no adverse effects on the patient.This was discovered during a uka procedure on (b)(6) 2024, with no patient harm reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-611-7 serial/batch number (b)(6) was received for investigation.No functional testing was performed as it doesn't apply to this device.A visual evaluation revealed that the tip of the device was broken off.The most likely cause(s) of the reported failure is the instrument's wear and tear from repetitive use and reprocessing.Instrument 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: 20303539
• Report Number: 1220246-2024-07849
• Device Sequence Number: 21049392
• Product Code: LXH
• UDI-Device Identifier: 00888867240346
• UDI-Public: 00888867240346
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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, TIBIA TRIALING SHIM 2/3MM
• Device Catalogue Number: AR-611-7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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