BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMENT

    MDR report key: 3162220 · Received June 11, 2013

    Report

    Report Number
    1045834-2013-02387
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION COULD NOT BE DUPLICATED OR CONFIRMED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTACHMENT DEVICE COULD NOT BE ATTACHED TO A MOTOR DEVICE. IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY, IF THERE WERE ANY DELAYS TO A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS UNKNOWN TO THE REPORTER IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262013 6.5CM ADULT CRANI ATTACHMENT MOTOR, DRILL, ELECTRIC-CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1