BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA TWIST DRILL

    MDR report key: 4116950 · Received September 22, 2014

    Report

    Report Number
    2025102-2014-00002
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    October 16, 2013
    Report Date
    September 18, 2014
    Manufacturer
    BRASSELER USA, MEDICAL, LLC
    Product Code
    GFF
    PMA / PMN Number
    K943758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSPECTION RECORDS SHOWED NO ANOMALIES FOR THIS LOT. THE RETURNED UNUSED TWIST DRILL WAS FOUND TO BE IN SPECIFICATIONS. THE RETURNED BROKEN TWIST DRILL WAS TESTED AND FOUND TO BE IN SPECIFICATION FOR HARDNESS. AT THE BREAK, THE TWIST DRILL SHOWED EVIDENCE OF ROTATIONAL DEFORMATION THAT WOULD BE EXPERIENCED BY A DRILL THAT WAS BIDING IN THE BONE OR METAL FIXTURE.

    Description of Event or Problem · 1

    TIP OF TWIST DRILL BROKE OFF IN PT DURING SURGICAL PROCEDURE. DOCTOR ELECTED TO LEAVE BROKEN PIECE IN PT. NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587493 BRASSELER USA TWIST DRILL TWIST DRILL GFF BRASSELER USA, MEDICAL, LLC KM166-310-25 NH1A8

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR