BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 3392657 · Received October 8, 2013

    Report

    Report Number
    1719045-2013-02000
    Event Type
    Malfunction
    Date Received
    October 8, 2013
    Date of Event
    September 16, 2013
    Report Date
    September 16, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4). ADDITIONAL PRODUCT CODE: HSZ. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013 A DRILL BIT BROKE DURING DRILLING FOR A LAG SCREW IN A FIBULA ON THE RIGHT SIDE OF THE PATIENT. THE DRILL BIT WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY REPORTED. THERE WAS A 15 MINUTE DELAY IN COMPLETING THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510728 2.5MM DRILL BIT/QC/GOLD/110MM HTW SYNTHES MONUMENT U172578

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR