BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER US A BUR

    MDR report key: 4209527 · Received October 23, 2014

    Report

    Report Number
    2025102-2014-00003
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    July 25, 2014
    Report Date
    October 23, 2014
    Manufacturer
    BRASSELER USA, MEDICAL L.L.C.
    Product Code
    GFF
    PMA / PMN Number
    K943758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SWANSON BUR BROKE OFF IN THE PATIENT'S BONE AND IT WAS UNABLE TO BE REMOVED. PIP REPLACEMENT, RIGHT MIDDLE FINGER. THE SWANSON BUR FROM THE DISPOSABLE PACK BROKE OFF IN THE PATIENT'S BONE OF THE RIGHT HAND MIDDLE FINGER DURING SURGERY AND IT WAS UNABLE TO BE REMOVED BY THE SURGEON. THERE WAS NO INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676438 BRASSELER US A BUR PIP-DIS-HAL GFF BRASSELER USA, MEDICAL L.L.C. PIP-DIS-HAL ND1B5

    Patients

    Seq Age Sex Outcome Treatment
    1