BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT FOR 8.0MM SCREW

    MDR report key: 6908391 · Received October 2, 2017

    Report

    Report Number
    3008951116-2017-00009
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 29, 2017
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HTW
    UDI-DI
    05055662956146
    PMA / PMN Number
    K163489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED REGARDING A RESIDUE FOUND INSIDE THE CANNULATION OF THE DRILLS. THIS RESIDUE WAS IDENTIFIED AS RUST. A SERIES OF TESTS WERE CONDUCTED TO RULE OUT AND IDENTIFY THE ROOT CAUSE HOWEVER IT IS YET TO BE DETERMINED. IN THE MEANTIME A RECALL WILL BE INITIATED TO REMOVE THE PRODUCTS FROM THE FIELD WHILE ORTHO SOLUTIONS CONTINUES TO INVESTIGATE THIS COMPLAINT. MATERIAL CHEMICAL COMPOSITION TEST AND DEVICE HISTORY RECORD REVIEW SHOWED THE PRODUCT WAS MADE TO APPROVED SPECIFICATION. FURTHER TEST WERE CONDUCTED ON IDENTIFICATION OF RESIDUE VIA EDX. TESTS ARE ALSO BEING CONDUCTED TO RE-CHECK THE SUGGESTED DRYING TIME FOR STEAM STERILISATION VALIDATION. THE REPORTED TEMPERATURE AND TIMELINE WAS ALREADY VALIDATED FOR THIS SYSTEM VIA INDEPENDENT LABORATORY. FURTHER REPORT WILL BE SUBMITTED WHEN RECALL IS INITIATED AND/OR ROOT CAUSE IS IDENTIFIED.

    Description of Event or Problem · 1

    BROWN RESIDUE WAS FOUND INSIDE THE CANNULATION OF THE DRILLS. IT WAS FOUND DURING CLEANING AND WAS NOT USED ON THE PATIENT. ORTHO SOLUTIONS HAVE SINCE CONDUCTED A SERIES OF TEST AND THE RESIUDE WAS IDENTIFIED AS EARLY STAGE RUST. CURRENTLY ROOT CASE BEING INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687402 DRILL BIT FOR 8.0MM SCREW DRILL BIT HTW ORTHO SOLUTIONS UK LTD OS900041-NS 1091648 05055662956146

    Patients

    Seq Age Sex Outcome Treatment
    1