MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION TIBIAL TOWER NON-CEM #6-#7; TIBIAL GUIDE

Model Number	9404-2903
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	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The problem may be caused by an inappropriate usage.While encountering to dense bone, the surgeon should use the tibial peg drill to make four pilot holes before positioning the tibial tower onto the tibial baseplate trial, otherwise the device breakage might happened.On the other hands, the device manufacturing manner of the spike part has been revised from onepiece machining to welding to further enhance the device strength.
Event or Problem Description
The surgeon removed tibial tower component #6~#7 after applying force (punching) to the patient's knee.Upon inspection, the surgeon found that spike within the tibial tower was broken.The broken piece was found in the bone and safely extracted using a rongeur tool.After removing the broken spike, the surgeon proceeded with the rest of the planned surgical procedure.The tibial tower had already served its intended purpose prior to its removal, so the broken spike did not compromise the surgical outcome.There was a 5-minute delay in the surgery to remove the broken spike, agent provided feedback that this delay did not have any impact on the patient or the overall success of the surgery.Replacement instrument was sent to the agent and the agent was requested to return the broken instrument for evaluation.

• Brand Name: TIBIAL TOWER NON-CEM #6-#7
• Common Device Name: TIBIAL GUIDE
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no. 57, park ave. 2; science park; hsinchu city, 30075 ; TW 30075
• Manufacturer (Section G): UNITED ORTHOPEDIC CORPORATION; no. 57, park ave. 2; science park; hsinchu city, 30075 ; TW 30075
• Manufacturer Contact: lois ho ; no. 57, park ave. 2; science park; hsinchu city, 30075 ; TW 30075
• MDR Report Key: 22067375
• Report Number: 9681642-2025-00008
• Device Sequence Number: 18334525
• Product Code: LXH
• UDI-Device Identifier: 04719886892130
• UDI-Public: (01)04719886892130(10)22G861
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 05/22/2025

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: 9404-2903
• Device Lot Number: 22G861
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male