MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULTRA-DRIVE III CONSOLE; DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT

Model Number	ULTRA-DRIVE 3
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
When surgeon was attempting to use the ultra-drive handpiece, it caught on fire.The flame did touch the surgeon and he took off his gown and gloves and checked for any signs of injury/burn(s).No injuries/burns were noted.The ultra-drive handpiece and generator were taken out of service.Management was notified.Hc3 or 6.No harm to the patient.Hecc: 4582.Dpc: 1245.

• Brand Name: ULTRA-DRIVE III CONSOLE
• Common Device Name: DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.
• MDR Report Key: 24741077
• Report Number: MW5186133
• Device Sequence Number: 12266237
• Product Code: JXE
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ULTRA-DRIVE 3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male