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	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a knee arthroplasty, one spike on the tibial tower instrument broke while being removed after performing keel punch impaction procedure.The surgeon identified the one broken spike on the tibial baseplate and carefully removed the spike from the tibial baseplate and continued with the surgery, there was no delay in the case.This complication occurred after the tibial preparation was complete, so it did not affect patient outcomes or significantly delay the overall procedure.The tibial tower instrument was no longer needed for the remaining steps of the surgery.Replacement instrument was sent to the agent and the agent was requested to return the broken instrument for evaluation.
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 #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: 21176314
• Report Number: 9681642-2025-00003
• Device Sequence Number: 20968994
• Product Code: LXH
• UDI-Device Identifier: 04719886892123
• UDI-Public: (01)04719886892123
• 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): 01/08/2025

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: 9404-2902
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown