BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE

    MDR report key: 3984027 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16192
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    April 5, 2011
    Report Date
    April 13, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES. THE DEVICE IS CURRENTLY UNDERGOING EVAL. ONCE THE EVAL HAS BEEN COMPLETED OR IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SENT. REF: # (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THEY WOULD LIKE THE DEVICE EVALUATED WITH THE MOTOR AND FOOT PEDAL SINCE THE DRILL ONLY SPINS AS 1000 RPM'S DURING SURGERY. THERE WERE NO USER OR PT INJURIES. IT IS UNK IF MEDICAL INTERVENTION OR SURGICAL DELAY OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663056 SYSTEM CONSOLE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1