BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CAN. FULL THICKNESS DRILL

    MDR report key: 10777412 · Received November 3, 2020

    Report

    Report Number
    8043971-2020-05220
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    August 31, 2020
    Report Date
    August 31, 2020
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    MBI
    UDI-DI
    01081019001645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING DEPARTMENT FOUND THAT THE INSTRUMENT IS WORN, IT WAS USED FOR A LONG PERIOD OF USES CAUSING THE EDGES OF INSTRUMENT TO BE WORN OUT. IT WAS CONCLUDED AS MISUSE IN ACCORDANCE WITH IFU234CDST REV 'G' THE INSTRUMENTS SHOULD BE REPLACED AFTER ONE YEAR. (DEVICE PRODUCES ON APR-2017) INSTRUMENTS PROVIDED NON-STERILE IN ACCORDANCE WITH IFU234CDST REV 'G' PRODUCT SUPPLIED NON STERILE, THE END USER SHOULD INSPECT THE INSTRUMENTS BEFORE USE FOR INTEGRITY AND COMPATIBILITY IN ORDER TO ENSURE PROPER FUNCTIONALITY AND SAFETY.

    Description of Event or Problem · 1

    THE INTERNAL DRILL WAS AFFECTED BY THE DRILL ABOVE AND METAL ABRASION OCCURRED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH THE AFFECTED ITEMS. THE METAL ABRASION WAS ABLE TO BE REMOVED FROM THE PATIENT. SURGICAL DELAY OF 15MIN. NOT LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241063 4.5MM CAN. FULL THICKNESS DRILL 4.5MM CAN. FULL THICKNESS DRILL MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD 234040045 17B01 01081019001645

    Patients

    Seq Age Sex Outcome Treatment
    1