BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR II FOR BPL II

    MDR report key: 4102664 · Received September 19, 2014

    Report

    Report Number
    2520274-2014-13754
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE TURNING KNOB WAS DAMAGED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO MISHANDLING AS IT APPEARED THAT THE DEVICE HAD BEEN DROPPED, WHICH IS MISUSE, ABUSE, AND/OR USER ERROR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SAWBONES LABORATORY, IT WAS DISCOVERED THAT THE SAW BLADE ON THE BATTERY OSCILLATOR DEVICE WAS SHAKING LOOSE UPON USE. ACCORDING TO THE REPORT, THE SAW BLADE DEVICE FIT AND SNAPPED INTO THE DEVICE. HOWEVER, ONCE THE DEVICE STATED TO SHAKE, IT WAS OBSERVED THAT THE SAW BLADE DEVICE WOULD FALL OUT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO 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
    582292 BATTERY OSCILLATOR II FOR BPL II MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SAW BLADE DEVICE