BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM F/A2FN

    MDR report key: 3080723 · Received April 26, 2013

    Report

    Report Number
    2520274-2013-02172
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    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)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY, A NAIL WAS BEING INSERTED USING RECON SCREWS. THE DISTAL GUIDE WIRE WAS INSERTED FIRST. IT WAS SITTING OFF CENTER IN THE HOLE OF THE NAIL. THE PROXIMAL GUIDE WIRE MISSED THE NAIL COMPLETELY. THE SURGEON USED THE REAMER TO DRILL THE NAIL. THE RECON SCREWS WERE NOT SITTING PARALLEL TO EACH OTHER. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182583 AIM-ARM F/A2FN JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1