MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION TIBIAL TOWER NON-CEM #3-#5; TIBIAL GUIDE

Model Number	9404-2902
Medical Device Problem Codes	Break (1069); Material Separation (1562); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem may be caused by improper usage.When encountering dense bone, the surgeon should use the tibial peg drill to create four pilot holes before positioning the tibial tower onto the tibial baseplate trial.Failing to do so could result in device breakage.Additionally, the manufacturing process for the spike part has been revised.Instead of one-piece machining, the spike is now produced through welding of the spikes.This change has been implemented to further enhance the overall strength of the device.
Event or Problem Description
The peg on the tibial tower broke during the attachment process to the tibia trial.The breakage occurred while tapping the top of the tibial tower and removing it after preparing the tibia.The broken peg was easily recovered when the tibia trial tray was removed.The surgery was completed successfully, and the patient was not affected.There was no significant delay, as the tibia preparation was already completed, and no further use of the instrument was needed.

• Brand Name: TIBIAL TOWER NON-CEM #3-#5
• Common Device Name: TIBIAL GUIDE
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no. 57, park ave. 2; hsinchu city, 30075 ; TW 30075
• MDR Report Key: 19160183
• Report Number: 3009760038-2024-00019
• Device Sequence Number: 7856350
• Product Code: LXH
• UDI-Device Identifier: 04719886892123
• UDI-Public: (01)04719886892123(10)23C960
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2024
• Report Date (Section F): 04/22/2024

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 Model Number: 9404-2902
• Device Lot Number: 23C960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/25/2024
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/22/2024