MAUDE Adverse Event Report: UNITED ORTHOPEDIC 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	12/12/2023
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
Dr.Removed the tibial tower using the slotted hammer with the punch and punch adapter inside the tower per standard surgical protobol after preparing the tibial keel.Upon inspection it was a noted both anterior spikes on the tibial tower had broken, both spikes remained in the tivial plateau and were removed using a kocher clamp.The surgeon said this patient had hard bone.There was a minimal delay int he case to remove the spikes, and case was competed successfully.

• Brand Name: TIBIAL TOWER, NON-CEM, #3-#5
• Common Device Name: TIBIAL GUIDE
• Manufacturer (Section D): UNITED ORTHOPEDIC; 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: 19131677
• Report Number: 9681642-2024-00013
• Device Sequence Number: 6891281
• Product Code: LXH
• UDI-Device Identifier: 04719886892123
• UDI-Public: (01)04719886892123(10)22G858
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/28/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/18/2024
• 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 Age: 57 YR
• Patient Sex: Female