BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 2942970 · Received February 5, 2013

    Report

    Report Number
    2530088-2013-00108
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 9, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THE O.R. DIRECTOR REPORTED FIVE (5) SCREWDRIVERS THAT WERE PEEL PACKED INDIVIDUALLY WHILE GOING THROUGH STERILIZATION, LEFT A GREASY SUBSTANCE ON THE INSIDE OF THE PACKAGE WHEN OPENED UP. THE O.R. STAFF DOES NOT FEEL THEY ARE STERILE DUE TO THE GREASY SUBSTANCE AND FEEL THEY COULD BE A POTENTIAL PROBLEM. THE SALES CONSULTANT BELIEVES THESE WERE NOT INVOLVED IN A SURGERY AND THAT THEY ARE PROACTIVELY BEING REPORTED BY THE HOSPITAL. THIS IS 4 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48385 4.0MM HEXAGONAL SCREWDRIVER HEXAGONAL SCREWDRIVER HXX SYNTHES BRANDYWINE 5139672

    Patients

    Seq Age Sex Outcome Treatment
    1