BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 2942969 · Received February 5, 2013

    Report

    Report Number
    2530088-2013-00109
    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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE DHR WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    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.

    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 5 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47555 4.0MM HEXAGONAL SCREWDRIVER HEXAGONAL SCREWDRIVER HXX SYNTHES BRANDYWINE 5005727

    Patients

    Seq Age Sex Outcome Treatment
    1