BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA

    MDR report key: 1960420 · Received December 16, 2010

    Report

    Report Number
    2025102-2010-00015
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BRASSELER USA MEDICAL
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED. PRODUCT OF THE SAME LOT NUMBER WAS OBTAINED FROM INVENTORY AND IS IN THE PROCESS OF TESTING.

    Description of Event or Problem · 1

    A DISPOSABLE SURGICAL INSTRUMENT PACKAGE WAS BEING USED DURING A SURGICAL PROCEDURE WHERE THE TIP OF A SIDE CUTTING BUR BROKE OFF IN THE PATIENT. THE SIDE CUTTING BUR WAS BEING USED TO PREPARE A PROXIMAL INTERPHALANGEAL JOINT FOR A PROSTHESIS. THE SURGEON DID NOT RETRIEVE THE BROKEN PIECE AND LEFT IT IN THE PATIENT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRASSELER USA GFF BRASSELER USA MEDICAL PIP-DIS-STR NB2V3

    Patients

    Seq Age Sex Outcome Treatment
    1