BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 6096861 · Received November 11, 2016

    Report

    Report Number
    1045834-2016-13204
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 11, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE REFLECTED HEAT WITH A READING OF 119 DEGREES FAHRENHEIT WHICH IS GREATER THAN MANUFACTURE SPECIFICATION (119 DEGREES FAHRENHEIT; SPECIFIED READING IS TEMPERATURE SHALL NOT EXCEED 118 DEGREES FAHRENHEIT), THE UNIT REFLECTED A CONSOLE ROTATIONS PER MINUTE (RPM) WITH A READING OF 54,000 RPM WHICH IS LESS THAN MANUFACTURE SPECIFICATION (54,000 RPM; SPECIFIED READING IS 80,000 RPM), THE UNIT REFLECTED AN INSTRUMENT READING OF 86,868 RPM WHICH IS LESS THAN MANUFACTURE SPECIFICATION (86,868 RPM; SPECIFIED READING IS BETWEEN 79,000-81,000 RPM). THE DEVICE ALSO FAILED THE FOLLOWING PRE-TESTS: THERMISTOR ASSESSMENT AND HAND CONTROL ASSESSMENT. IT WAS ALSO NOTED THAT THE FLEX CIRCUIT POTTING WAS CRACKED AND THE MOTOR WAS WORN OUT. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR FROM USE 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 THE MOTOR DEVICE WAS NOT FUNCTIONING CORRECTLY. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE WAS OVERHEATING AND HAD LOW ROTATIONS PER MINUTE. THE EVENT WAS NOT REPORTED TO HAVE OCCURRED DURING SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS UNKNOWN IF THERE WAS 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 WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748161 EMAX 2 MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1