MAUDE Adverse Event Report: BIOMET, INC. ULTRA-DRIVE; INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2020

Event Type  malfunction  

Event Description

While the surgeon was using the ultra drive tring to remove an implant from the right femur, the electrical cable caught on fire.The fire was immediately extinguished, and the equipment was removed from the field.No one was injured and the sterile field remained intact.

• Brand Name: ULTRA-DRIVE
• Type of Device: INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): BIOMET, INC.; 56 east bell dr.; po box 587; warsaw IN 46581
• MDR Report Key: 10785241
• MDR Text Key: 214564712
• Report Number: 10785241
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Date Report to Manufacturer: 11/04/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA