BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 6670940 · Received June 27, 2017

    Report

    Report Number
    8030965-2017-13295
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    June 2, 2017
    Report Date
    June 6, 2017
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER MAINTENANCE, WHICH IS USER ERROR/MISUSE/ABUSE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    CORRECTION: PLEASE NOTE THAT THE INCORRECT PMA/510(K) NUMBER WERE INADVERTENTLY DOCUMENTED AS EXEMPT IN THE INITIAL MEDWATCH REPORT. PLEASE NOTE THAT THE CORRECT NUMBER (K043310) HAS BEEN DOCUMENTED OF THIS MEDWATCH REPORT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ELECTRIC PEN DRIVE DEVICE MOTOR WAS NOT FUNCTIONING AND WAS DEFECTIVE. IT WAS NOTED THAT THE DEVICE NO LONGER WORKED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION AND DIRECTION OF ROTATION, CHECK FUNCTION WITH TEST HAND SWITCH, CHECK FUNCTION WITH FOOT PEDAL, AND CHECK POWER WITH TEST BENCH. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT TURN ON. 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 WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450348 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