BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT, MINI AO, 1.2MM, CALIBRATED

    MDR report key: 11912013 · Received June 1, 2021

    Report

    Report Number
    1220246-2021-03182
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 14, 2021
    Report Date
    June 1, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867312678
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE AR-18700-14 AND AR-18700-12 DRILL BITS BROKE. THE SALES REP STATED THAT THE BARS ARE CATCHING. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814060 DRILL BIT, MINI AO, 1.2MM, CALIBRATED BIT, DRILL HTW ARTHREX, INC. DRILL BIT, MINI AO, ¿1.2MM, CALIBRATED 022040 00888867312678

    Patients

    Seq Age Sex Outcome Treatment
    1