BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 4200518 · Received October 24, 2014

    Report

    Report Number
    2520274-2014-14315
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 10, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. THE DEVICE MANUFACTURE DATE IS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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 AN ORIS OF THE DISTAL RADIUS SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE HANDLE WAS LOCKED OFF CENTER ON THE SMALL BATTERY DRIVE DEVICE. THERE WAS A FIVE MINUTE DELAY TO THE PLANNED SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. 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
    678853 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1