MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 7; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 7
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per wi-000101075 rev.24.0, product history reviews are required for all complaints classified as an early warning or adverse event and any complaint where investigation reveals a confirmed cause category of design, process, product, or supplier.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.
Event or Problem Description
On 1/11/2022, it was reported by a sales representative via email that an ar-513-t7 tka tibial tray modular center screw was loose.Surgeon was able to use the screw and used the screwdriver in the tray to tighten it down.The surgeon felt that the screw did engage and felt confident the product was okay to implant into the patient.No other devices needed to be opened to complete.This was discovered during a total knee arthroplasty procedure.

• Brand Name: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 7
• Common Device Name: KNEE PROSTHESIS PAT/FEM/TIB
• 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: 19277167
• Report Number: 1220246-2024-03002
• Device Sequence Number: 12660549
• Product Code: MBH
• UDI-Device Identifier: 00888867187900
• UDI-Public: 00888867187900
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K171365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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 Expiration Date: 07/31/2026
• Device Model Number: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 7
• Device Catalogue Number: AR-513-T7
• Device Lot Number: 14042481
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown