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	08/21/2024
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 one-piece machining to welding to further enhance the device strength.
Event or Problem Description
The surgeon removed tibial tower components # 3~# 5 after applying force (punching) to the patient's knee.Upon inspection, the surgeon found that two spikes within the tibial tower was broken and had become embedded in the patient's bone.The surgeon utilized a specialized tool called a "rongeur" to carefully remove the broken spikes from the patient's bone.After removing the broken spikes, 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.This brief 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 #3-#5
• 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: 21023805
• Report Number: 9681642-2024-00035
• Device Sequence Number: 12853880
• Product Code: LXH
• UDI-Device Identifier: 04719886892123
• UDI-Public: (01)04719886892123(10)22G858
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/24/2024

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: 22G858
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown