BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT ROTATING CRANIOTOME

    MDR report key: 3811821 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-04206
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE CAME APART. THE DEVICE WAS BEING USED DURING SURGERY. NO PATIENT INJURY; HOWEVER, IT IS UNKNOWN IF THERE WAS ANY MEDICAL INTERVENTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524596 ADULT ROTATING CRANIOTOME MOTOR, DRILL, ELECTRIC - CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1