BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-DRIVE® TOOL

    MDR report key: 16101688 · Received January 5, 2023

    Report

    Report Number
    16101688
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 2, 2022
    Report Date
    December 29, 2022
    Manufacturer
    BIOMET ORTHOPEDICS, LLC
    Product Code
    JDX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING OPERATION OF THE ULTRA-DRIVE® TOOL (TOOL FOR CEMENT REMOVAL), THE TIP BROKE OFF. GOOD TECHNIQUE WAS USED DURING OPERATION. PHYSICIAN WAS ABLE TO VISUALIZE THE BROKEN PIECE WITH C-ARM. HEALTHCARE PROVIDERS WERE THEN ABLE TO REMOVE THE REMAINING CEMENT AS WELL AS THE CEMENT PLUG AND THE CEMENT RESTRICTOR USING THE ULTRA-DRIVE AND OSTEOTOMES. HEALTHCARE PROVIDERS WOULD ALSO NOTICED THAT OF A SMALL PORTION OF THE ULTRA-DRIVE OSTEOTOME'S TIP BROKE OFF ADJACENT TO THE FEMUR. PER THE SURGEON: THERE WAS NOTHING TO BE DONE DIFFERENTLY, I WAS USING THE EQUIPMENT PER MANUFACTURER'S INSTRUCTIONS. I ATTEMPTED TO REMOVE THE BROKEN TIP BUT COULD NOT GET IT OUT. I BELIEVE IT IS EMBEDDED IN THE BONE. THERE SHOULD BE NO ADVERSE OUTCOMES DUE TO THE TIP BREAKAGE. IT WAS DECIDED BY SURGEON TO LEAVE RETAINED PIECE AS IT WAS DEEMED IRRETRIEVABLE. ULTRADRIVE TOOL (REF #423883; LOT #183140) 6.5MM STRAIGHT KNEE OSTEOTOME. BIOMET ORTHOPEDICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098272 ULTRA-DRIVE® TOOL INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT JDX BIOMET ORTHOPEDICS, LLC 423883 183140

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA Male Other