BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 3062334 · Received April 16, 2013

    Report

    Report Number
    1719045-2013-01093
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. ADDITIONAL PRODUCT CODE - HSZ.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE OF THE HUMERUS ON (B)(6) 2013, AS THE SURGEON WAS DRILLING A HOLE, THE DRILL BIT TIP BROKE CLEANLY INTO THE BONE. THE PROCEDURE WAS COMPLETED, BUT THE BROKEN PORTION OF THE DRILL BIT REMAINED IN PATIENTS BONE. SURGERY WAS COMPLETED AS PLANNED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163410 2.5MM DRILL BIT/QC/GOLD/110MM HTW SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR