BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI II

    MDR report key: 6701358 · Received July 11, 2017

    Report

    Report Number
    8030965-2017-13559
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 14, 2017
    Report Date
    June 16, 2017
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT 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 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 MOTOR ON THE SMALL BATTERY DRIVE DEVICE MOTOR DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR: CHECK THE TRIGGERS AND ELECTRONIC CONTROL UNIT (ECU) FUNCTION, CHECK THE OFF/OSCION SWITCH MODE FUNCTION, CHECK THE OSCILLATION ANGLE, CHECK SWITCHING FUNCTION, CHECK THE FUNCTION WITH EPD-CONSOLE, CHECK COMPATIBILITY BETWEEN COLLBRLLSBD AND COLLBRI II /SBD II AND CHECK POWER WITH TEST BENCH, MLN.67.5 TO 110W. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK ANYMORE. 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
    480590 COLIBRI II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1