BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA TWIST DRILL

    MDR report key: 5816891 · Received July 22, 2016

    Report

    Report Number
    2025102-2016-00005
    Event Type
    Malfunction
    Date Received
    July 22, 2016
    Date of Event
    June 23, 2016
    Report Date
    July 22, 2016
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFF
    PMA / PMN Number
    K943758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. IF THE DRILL WAS NOT PROPERLY HELD STRAIGHT WHEN CHUCKED IN THE COLLET, IF ANY EXCESSIVE, BENDING, OR LATERAL FORCES ARE USED, IF THE DRILL CAME INTO CONTACT WITH ANY METAL OBJECTS DURING USE, AND IF THE DRILL MAY HAVE BEEN INADVERTENTLY BENT DURING PREPARATION, THESE SCENARIOS AMONG OTHERS MAY CONTRIBUTE TO THE DRILL BENDING AND BREAKING DURING USE. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. THE MANUFACTURED LOT NL6GD DHR WAS REVIEWED AND IDENTIFIED TO BE MANUFACTURED WITHIN SPECIFICATIONS WITH NO ANOMALIES FOUND. WITH THE INFORMATION PROVIDED AND WITH THE PREPARATION METHODS AND SURGICAL TECHNIQUES UNKNOWN A SPECIFIC CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING A BILATERIAL QUADREPES TENDON REPAIR, WHEN THE TWIST DRILL BROKE OFF IN THE PATIENT. BROKEN PIECE WAS LEFT IN PATIENT. DOCTOR WAS USING SYNTHES SMALL BATTERY DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468776 BRASSELER USA TWIST DRILL TWIST DRILL GFF BRASSELER U.S.A. MEDICAL, LLC KM166-10-01 NM0UX

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR