BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT 2/1.15 CANNULATED 150MM

    MDR report key: 3595844 · Received January 28, 2014

    Report

    Report Number
    2520274-2014-00089
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    December 26, 2013
    Report Date
    January 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    K951304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: HSZ, GFA, AND GFF. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BITS JUST SUDDENLY BREAK WHILE DRILLING IT INTO THE NAVICULAR BONE. THE PATIENT IS STABLE AND NO HARM HAPPENED. IT ONLY TOOK 5 MINUTES FOR THE DURATION IN REMOVING THE BROKEN PIECES. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62367 DRILL BIT 2/1.15 CANNULATED 150MM HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR