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	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) had completed his tibial punching, and while removing the size 6-7 tibial tower, he noticed one of the tower spikes had broken off.The spike was located on the tibial plateau and removed.The case was completed successfully, there was no delay in the case, and the patient was unaffected.Patient bone was slightly harder than average, per (b)(6) (agent present when surgery was performed).
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.

• 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: 24197197
• Report Number: 9681642-2026-00002
• Device Sequence Number: 15947473
• Product Code: LXH
• UDI-Device Identifier: 04719886892130
• UDI-Public: (01)04719886892130(10)22G861
• 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

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2026
• 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