BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR PIEZOELECTRIC SYSTEM

    MDR report key: 3731098 · Received April 7, 2014

    Report

    Report Number
    3009450871-2014-10056
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Report Date
    March 10, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    JDX
    PMA / PMN Number
    PK100410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE EVENT COULD NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY AND/OR DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOTOR DEVICE WAS "WORKING INTERMITTENTLY". IT WAS FURTHER CLARIFIED THAT THE DEVICE WAS RETURNED FROM A TRAINING COURSE. THIS EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURY OR MEDICAL INTERVENTION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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
    207741 HAND PIECE FOR PIEZOELECTRIC SYSTEM SONIC SURGICAL INSTRUMENT AND ACCESSORIES/ ATTACHMENTS JDX DEPUY SYNTHES POWER TOOLS 203965.048

    Patients

    Seq Age Sex Outcome Treatment
    1