BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM DRILL BIT

    MDR report key: 2982956 · Received February 26, 2013

    Report

    Report Number
    1719045-2013-10109
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 13, 2011
    Report Date
    January 14, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HWE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR EXAMINATION AND IT WAS NOTED THAT THERE WAS SIGNIFICANT CORROSION. SPECIFICATION INVESTIGATION DEMONSTRATED THAT THE PART MET SPECIFICATIONS. THE CAUSE OF THE CORROSION WAS UNKNOWN. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BITS AND SCREW TRAY ARE RUSTING IN THE MANDIBLE SET. THERE WAS NO PT IMPACT, AS THE ISSUE WAS DISCOVERED OUTSIDE THE OPERATING ROOM WHEN STOCKING THE SET. THIS IS REPORT 5 OF 6 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81778 1.8MM DRILL BIT HWE HTW SYNTHES (USA) MONUMENT U190123

    Patients

    Seq Age Sex Outcome Treatment
    1