BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER W/HUDSON END

    MDR report key: 4221608 · Received November 3, 2014

    Report

    Report Number
    1045834-2014-14690
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR REPAIR. DURING SERVICE AND REPAIR PRE-TESTING, IT WAS OBSERVED THAT THE DEVICE HAD NO ROTATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE GEAR BOX WAS SEIZED UP AND THERE WAS NO ROTATION. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMMERSION DURING CLEANING, WHICH IS FAILURE TO FOLLOW THE DIRECTIONS FOR USE. THIS WAS FURTHER DEFINED AS MISUSE, ABUSE, AND POSSIBLY USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS OBSERVED THAT THE COMPACT SPEED REDUCER HAD NO ROTATION. THE EVENT WAS NOT RELATED TO 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
    702796 PERFORATOR DRIVER W/HUDSON END DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER HBE DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1