BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL DRILL BITS AND ACCESSORIES

    MDR report key: 9673867 · Received February 5, 2020

    Report

    Report Number
    2183456-2019-00040
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    August 2, 2018
    Report Date
    February 5, 2020
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORPORATION
    Product Code
    HBE
    UDI-DI
    008411823106520
    PMA / PMN Number
    K170442
    Removal / Correction Number
    2183456-08212019-R-004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 2183456-2019-00040 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-2183456-2019-00040 WAS SUBMITTED AS A CONSERVATIVE MEASURE DUE TO THE RECALLS TIED TO THIS ISSUE.

    Description of Event or Problem · 1

    ON AUGUST 8, 2018, AN AD-TECH REGULATORY AFFAIRS SPECIALIST RECEIVED AN EMAIL REPORTING THAT THE DRILL BIT STUCK TO THE DRILL SLEEVE GUIDE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132870 CRANIAL DRILL BITS AND ACCESSORIES DRILL SLEEVE GUIDE HBE AD-TECH MEDICAL INSTRUMENT CORPORATION 712030 008411823106520

    Patients

    Seq Age Sex Outcome Treatment
    1 Other