BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEXAGONAL SCREWDRIVER

    MDR report key: 2942967 · Received February 5, 2013

    Report

    Report Number
    2530088-2013-00107
    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 DHR WAS REVIEWED AND MRR (B)(4) WAS FOUND ON 440A RAW MATERIAL LOT #X1363 FOR Ø A OVERSIZE. THE ME DETERMINED THAT 0.010MM OVERSIZE ON THE RAW MATERIAL DIAMETER WILL NOT AFFECT MANUFACTURING. THE ENGINEERING MANAGER ACCEPTED THE MATERIAL USE AS IS BECAUSE THERE IS NO AFFECT TO FIT OR FUNCTION. THIS NONCONFORMANCE IS NOT RELEVANT 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 OR 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 OR 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 3 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48384 LARGE HEXAGONAL SCREWDRIVER HEXAGONAL SCREWDRIVER HXX SYNTHES BRANDYWINE A4HY010

    Patients

    Seq Age Sex Outcome Treatment
    1