BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL DRILL BITS AND ACCESSORIES

    MDR report key: 9707043 · Received February 13, 2020

    Report

    Report Number
    2183456-2019-00036
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    June 20, 2018
    Report Date
    February 13, 2020
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORPORATION
    Product Code
    HBE
    UDI-DI
    0084182310652
    PMA / PMN Number
    K170442
    Removal / Correction Number
    2183456-08212019-R-004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 2183456-2019-00036 HAS BEEN FILED PAST THE 30-DAY TIMEFRAME. THROUGH THE 2019 FDA INSPECTION, IT WAS IDENTIFIED THAT WHILE AD-TECH WAS EVALUATING REPORTABILITY FOR ACTUAL EVENTS IN WHICH DEATH OR SERIOUS INJURY HAD OCCURRED, AD-TECH HAD FAILED TO SUBMIT EVENTS IN WHICH A MALFUNCTION WAS REPORTED AND COULD RESULT IN A SERIOUS INJURY IF THE EVENT WERE TO RECUR. AS PART OF THE INVESTIGATION, A TWO (2) YEAR RETROSPECTIVE REVIEW OF COMPLAINTS WAS PERFORMED TO DETERMINE WHICH COMPLAINTS REQUIRED SUBMISSION OF AN MDR. MDR-2183456-2019-00036 WAS SUBMITTED AS A CONSERVATIVE MEASURE DUE TO THE RECALLS TIED TO THIS ISSUE.

    Description of Event or Problem · 1

    ON JUNE 20, 2018, AN AD-TECH CLINICAL SPECIALIST RECEIVED A REPORT THAT THE DRILL BIT FUSED WITH THE DRILL SLEEVE GUIDE DURING THE 7TH TRAJECTORY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171901 CRANIAL DRILL BITS AND ACCESSORIES DRILL SLEEVE GUIDE HBE AD-TECH MEDICAL INSTRUMENT CORPORATION 815240 0084182310652

    Patients

    Seq Age Sex Outcome Treatment
    1 Other