BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASOR DRILL BIT

    MDR report key: 20662046 · Received November 12, 2024

    Report

    Report Number
    20662046
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 11, 2024
    Report Date
    November 7, 2024
    Manufacturer
    PHASER HEALTH LLC
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PHASE 2.7K DRILL SMOKING, HOT WHILE ATTEMPTING BOLT PLACEMENT. SALINE USED TO COOL DRILL. REPORTS OF MELTING BONE RELATED TO DRILL BIT HEAT. SALINE USED TO COOL DRILL. NEW DRILL OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059434 PHASOR DRILL BIT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE PHASER HEALTH LLC 2.70K 24082127S 2430559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown