BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 5904123 · Received August 25, 2016

    Report

    Report Number
    1045834-2016-12535
    Event Type
    Malfunction
    Date Received
    August 25, 2016
    Report Date
    July 6, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED IN THE INTIAL REPORT THAT DURING SERVICE AND REPAIR TESTING, IT WAS OBSERVED THAT THE CABLE/CORD/WIRING WAS DAMAGED, THE MOTOR AND CONTROL SYSTEM WAS DEFECTIVE (HAD LIQUID DAMAGE), THE COUPLING AND HOSE WERE DEFECTIVE, THE SET SCREW WAS LOOSE AND THERE WAS NO "U / MIN" DISPLAY ON THE MOTOR DEVICE. AFTER FURTHER EVALUATION IT WAS DETERMINED THAT THE DEVICE CABLE/CORD/WIRING WAS DAMAGED, THE MOTOR AND CONTROL SYSTEM WAS DEFECTIVE (HAD LIQUID DAMAGE), THE COUPLING AND HOSE WERE DEFECTIVE AND THE GRUB SCREW WAS LOOSE. IT WAS ALSO OBSERVED THAT THE DEVICE DID NOT DISPLAY ROTATIONS PER MINUTE, JAMMED WHILE ROTATING MANUALLY AND RAN AT TOWING CUT-OFF. 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

    (B)(4). (B)(6). THIS 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 IMPROPER CLEANING, WHICH IS USER ERROR/MISUSE/ABUSE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE CABLE/CORD/WIRING WAS DAMAGED, THE MOTOR AND CONTROL SYSTEM WAS DEFECTIVE (HAD LIQUID DAMAGE), THE COUPLING AND HOSE WERE DEFECTIVE, THE SET SCREW WAS LOOSE AND THERE WAS NO "U / MIN" DISPLAY ON THE MOTOR DEVICE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED THE FOLLOWING PRE-TESTS: LOCTITE AND CABLE ASSESSMENTS, MOTOR THERMISTOR ASSESSMENTS, HANDPIECE TEMPERATURE ASSESSMENT AND SAFETY ASSESSMENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS 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
    554510 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1