BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT ANGLED SCREWDRIVER

    MDR report key: 6989655 · Received October 31, 2017

    Report

    Report Number
    9681479-2017-00002
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    KMW
    UDI-DI
    J021300140001
    PMA / PMN Number
    K080939
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE SCREWDRIVER BECAME JAMMED AND GOT HOT. OBVIOUSLY, THE SPEED LIMITATION OF 10,000 RPM WAS NOT ADHERED TO. THE WS-90 ITSELF IS MARKED WITH THE INFORMATION TO USE AT A MAXIMUM MOTOR SPEED OF 10,000 RPM. NO INJURIES OCCURED. ALL OF THE TREATMENTS WERE COMPLETED SUCCESSFULLY WITHOUT A DELAY. NO INDICATION COULD BE FOUND IN THE INVESTIGATION OF ANY MATERIAL OR MANUFACTURING RELATED ISSUE. THE SCREWDRIVER FUNCTIONS AS INTENDED AND ACCORDING TO ITS SPECIFICATIONS. THE DEVICE IS ALREADY MARKED WITH THE INFORMATION TO USE ONLY AT A MAXIMUM SPEED OF 10,000 RPM.

    Description of Event or Problem · 1

    EVENT DESCRIPTION BY INITIAL REPORTER (B)(4): IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING A BSSO PROCEDURE, THE RIGHT ANGLE SCREWDRIVER BECAME JAMMED AND STARTED SMOKING. THE DEVICE WAS USED AT A SPEED OF 50,000 RPM'S DESPITE THE FACT THAT THE IFU STATES (AND THE RAS ITSELF IS MARKED WITH) THE INFORMATION TO USE AT A MAXIMUM MOTOR SPEED OF 10,000 RPM'S. THERE WERE NO ADVERSE EVENTS REPORTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY WITH A BACK UP DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771885 RIGHT ANGLED SCREWDRIVER WS-90 KMW W&H DENTALWERK BUERMOOS GMBH WS-90 01305 J021300140001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown