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

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	05/20/2024
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 onepiece machining to welding to further enhance the device strength.
Event or Problem Description
During the surgery surgeon was performing an activity that required impacting a tibial tower # 6~# 7 (pn:9404-2903) onto the patient's tibia with a mallet.Three pins on the tibial tower instrument broke while being impacted.The broken pins were retrieved after removing the trial tray, using a tonsil forceps.The surgeon ensured no pieces were left in the patient's body by examining and comparing the retrieved pins to the instrument.There was no impact on the patient or procedure as the tibial tower had already completed its function and broken pins were retrieved while removing the tibial tower.

• Brand Name: NON-CEM TIBIAL TOWER #6~#7
• Common Device Name: TIBIAL TOWER #6~#7
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no. 57, park ave. 2; science park; hsinchu city, 30075 ; TW 30075
• Manufacturer (Section G): UNITED ORTHOPEDIC; 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: 19768588
• Report Number: 9681642-2024-00026
• Device Sequence Number: 8725400
• Product Code: LXH
• UDI-Device Identifier: 04719886892130
• UDI-Public: (01)04719886892130(10)22M817
• 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: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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: 9404-2903
• Device Lot Number: 22M817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male