BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL GUIDE, 1.2 / 1.6MM

    MDR report key: 11912010 · Received June 1, 2021

    Report

    Report Number
    1220246-2021-03181
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 14, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867313798
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-18700-14, 1391932 DRILL GUIDE WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION WITH BOTH THE NAKED EYE AND UNDER MICRO-VU MAGNIFICATION IDENTIFIED THAT BOTH DRILL GUIDE TUNNELS WERE OCCLUDED BY DEBRIS, ESPECIALLY THE Ø1.6 END. THROUGH THE USE OF ADDED MICROSCOPE MAGNIFICATION AND LIGHTING, IT WAS DETERMINED THAT BOTH ENDS OF THE GUIDE WERE CLOGGED WITH TISSUE. THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF IMPROPER CLEANING/MAINTENANCE OF THE DRILL GUIDE.

    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
    814058 DRILL GUIDE, 1.2 / 1.6MM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. DRILL GUIDE, 1.2 / 1.6MM 1391932 00888867313798

    Patients

    Seq Age Sex Outcome Treatment
    1