BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA TWIST DRILL

    MDR report key: 6846438 · Received September 6, 2017

    Report

    Report Number
    2025102-2017-00004
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    July 17, 2017
    Report Date
    September 6, 2017
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFF
    PMA / PMN Number
    K943758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FDA MEDWATCH REPORT MW5071135 (B)(6). UNKNOWN DATE OF RECEIPT. NO PRODUCT RETURNED.

    Description of Event or Problem · 1

    PATIENT HAD SURGICAL REPAIR OF RUPTURED QUADRICEPS TENDON LEFT SIDE. A 1/16 DRILL BIT BROKE OFF IN THE PATIENT'S PATELLA DURING THE SURGICAL PROCEDURE. THE BROKEN BIT WAS RETRIEVED IN ITS ENTIRETY DURING THIS SURGICAL PROCEDURE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624127 BRASSELER USA TWIST DRILL TWIST DRILL GFF BRASSELER U.S.A. MEDICAL, LLC KM166-00-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R