BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 4879493 · Received June 30, 2015

    Report

    Report Number
    1423537-2015-00045
    Event Type
    Malfunction
    Date Received
    June 30, 2015
    Date of Event
    May 27, 2015
    Report Date
    June 30, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE INVOLVED IN THIS REPORTED INCIDENT HAS NOT BEEN RELEASED BY THE FACILITY AT THIS TIME. MULTIPLE ATTEMPTS TO EVALUATE THE DEVICE HAVE BEEN MADE AND WE HAVE BEEN INFORMED THAT AT THIS TIME THEY ARE UNABLE TO RELEASE THE DEVICE. THE DEVICE HISTORY RECORD¿S (2) FOR LOT 000440 WERE REVIEWED AND NO ANOMALIES WERE UNCOVERED. THE MATERIAL, MATERIAL HARDNESS, AND PROCESSING STEPS WERE VERIFIED BY THE SUPPLIER, PRECISION EDGE SURGICAL PRODUCTS COMPANY LLC. THE PRODUCT WAS MANUFACTURED TO REVISION M. NO ACTION IS REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR ANY SIMILAR REPORTS AND TAKE ACTION IF REQUIRED.

    Description of Event or Problem · 1

    ON MAY 27TH, DR (B)(6) WAS USING A 310.25EM DRILL BIT LOT 000440 TO DRILL SOFT BONE IN A (B)(6) FEMALE. HE NOTICED METAL DEBRIS COMING FROM THE DRILL SITE. HE WAS ABLE TO FLUSH THE AREA TO REMOVE THE SHAVINGS. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420736 2.5MM DRILL BIT/QC/GOLD/110MM 2.5 MM DRILL BIT HTW CARDINAL HEALTH 310.25.EM 000440

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other