BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA SURGICAL BUR

    MDR report key: 7304356 · Received February 28, 2018

    Report

    Report Number
    2025102-2018-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    January 23, 2018
    Report Date
    February 28, 2018
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFF
    PMA / PMN Number
    K943758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED TO EVALUATE. BUR WAS PART OF KIT ITEM 501124M0 - PIP-DIS-STR, LOT NN6UC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SILICONE PIP IMPLANT SURGERY ON (B)(6) 2018, A LONG THIN BUR BROKE INSIDE THE PATIENT'S PHALANGEAL WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE SURGEON TRIED USING SEVERAL TOOLS TO TRY AND REMOVE IT, BUT WAS UNABLE TO REMOVE THE BROKEN PIECE. THERE WAS A 15 MINUTE SURGICAL DELAY. NO PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145839 BRASSELER USA SURGICAL BUR SURGICAL BUR GFF BRASSELER U.S.A. MEDICAL, LLC AOI-14-S0201

    Patients

    Seq Age Sex Outcome Treatment
    1