BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-04470

    MDR report key: 3232652 · Received July 18, 2013

    Report

    Report Number
    2520274-2013-04470
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE GUIDE WIRE AND DRILL WAS HITTING THE NAIL WHEN INSERTED THROUGH THE RECON HOLES OF THE AIMING ARM. REPORTEDLY, THERE SEEMS TO BE SOME MOVEMENT BETWEEN THE GOLD SLEEVES AND THE AIMING ARM. AS THE SURGEON DRILLED THE SIDE OF THE NAIL HOLE, HE WAS CONCERNED IT MAY CREATE A WEAK SPOT. REPORTEDLY THERE WAS CONCERN THAT THE NAIL COULD POTENTIALLY FAIL OR BREAK IN THIS LOCATION. THIS REPORT IS FOR AN UNKNOWN GOLD SLEEVE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334610 HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR