BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 6098429 · Received November 14, 2016

    Report

    Report Number
    8030965-2016-15549
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 13, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTER¿S NAME, COMPLETE ADDRESS AND PHONE NUMBER WERE NOT PROVIDED. THE DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO DEVICE WEAR FROM NORMAL USE AND SERVICING. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT THE PEN DRIVE DEVICE WAS NOT WORKING. DURING AN IN HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE HANDPIECE RAN BY ITSELF AND FAILED PRE-TEST FOR HAND SWITCH. IT WAS ALSO NOTED THAT THE ELECTRONIC CONTROL UNIT WAS FAULTY AND THE MOTOR WAS NOISY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    750005 EPD 60000 RPM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1