BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMT

    MDR report key: 4093927 · Received September 16, 2014

    Report

    Report Number
    1045834-2014-12838
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND FOUND THE DEVICE TO HAD TEMPERATURE ABOVE SPECIFICATION. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR AND SERVICING OVER TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE CRANIOTOME DEVICE HAD TEMPERATURE ABOVE SPECIFICATION. THIS EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO INJURIES OR MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION ASSOCIATED WITH THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571334 6.5CM ADULT CRANI ATTACHMT MOTOR, DRILL, ELECTRIC - CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1