BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIT, DRILL

    MDR report key: 6167831 · Received December 12, 2016

    Report

    Report Number
    2134070-2016-00089
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    October 7, 2016
    Report Date
    November 15, 2016
    Manufacturer
    STERILMED, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A SUPPLEMENTAL FORM WILL BE SENT ONCE THE EVALUATION IS COMPLETED IF THE DEVICE IS RETURNED. THE DEVICE HISTORY REPORT WAS NOT REVIEWED AS NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    AN INCOMPLETE DRILL BIT WAS RETURNED MISSING ITS DISTAL HALF. THE DEVICE WAS BROKEN WHERE THE FLUTES IN THE SIDES OF THE BIT BEGIN. NO INDICATION OF METAL FATIGUE OR WEAKENING IN THE FORM OR RUST OR PITTING WAS FOUND TO BE PRESENT. THE ROOT CAUSE FOR THE DAMAGE IS UNCERTAIN BUT LIKELY LINKED TO ITS USE/MISUSE IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BIT BROKE INSIDE THE PATIENT DURING A PROCEDURE. NO PATIENT INJURY OR CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816589 BIT, DRILL HTW STERILMED, INC. SYN310.21

    Patients

    Seq Age Sex Outcome Treatment
    1