BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 4770057 · Received May 13, 2015

    Report

    Report Number
    3009450871-2015-11463
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 15, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. IT WAS FURTHER DETERMINED THAT THE DEVICE DID NOT RUN, DID NOT ENGAGE WHEN POWER WAS APPLIED, THE TRIGGERS JAMMED AND ONE COUPLING LEVER JAMMED. IT WAS NOTED THAT THE MOTOR WAS NOT FUNCTIONAL AND THE TRIGGER AND COUPLING HEAD COMPONENTS WERE WORN. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR ON MECHANICAL AND ELECTRONIC COMPONENTS FROM REPEATED STERILIZATION AND USE OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-SURGERY TESTING, BEFORE THE PATIENT ENTERED THE ROOM FOR A TIBIA PLATEAU FRACTURE REPAIR SURGERY, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE BECAME STUCK IN THE ¿ON¿ POSITION. IT WAS FURTHER REPORTED THAT THE DEVICE WAS TURNED OFF THEN WOULD NOT TURN BACK ON AGAIN. THE REPORTER STATED THAT TWO NEW BATTERY DEVICES WERE TRIED TO NO AVAIL. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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
    313999 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 002658

    Patients

    Seq Age Sex Outcome Treatment
    1