BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX DRIVER 1/4" SQUARE QC 4.0

    MDR report key: 8011017 · Received October 26, 2018

    Report

    Report Number
    3009051471-2018-00014
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    July 20, 2018
    Report Date
    October 24, 2018
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    LXH
    Removal / Correction Number
    300905147108022018-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WERE RECALLED FOLLOWING A COMPLAINT ON THE HEX DRIVER MISSING THE RETENTION RING. OUT OF ALL THE RECALLED DEVICES, THE LOT 7EQBB-C HAD 6 DEVICE MALFUNCTION. RETENTION RINGS FOR THE 6 DEVICES WERE FOUND MISSING. AFTER CORRESPONDENCE WITH THE FDA 6 DIFFERENT MDRS ARE BEING FILED FOR THE 6 DEVICES THAT MALFUNCTIONED IN THE LOT. THIS IS THE #5 REPORT #(B)(4).

    Description of Event or Problem · 1

    PARTS WERE RETURNED FROM SITE AND WERE MISSING THE RETENTION RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851033 HEX DRIVER 1/4" SQUARE QC 4.0 HEX DRIVER 1/4" SQUARE QC 4.0 LXH CTL MEDICAL CORPORATION 019.7050 7EQBB-C

    Patients

    Seq Age Sex Outcome Treatment
    1