BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASING FOR 12V BATTERY

    MDR report key: 3893536 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-12141
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 6, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. THE DATE OF MANUFACTURE WAS UNKNOWN. THE DEVICE WAS NOT 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 PRIOR TO SURGERY, IT WAS OBSERVED THAT THE BATTERY CASE DEVICE WAS NOT WORKING. THERE WERE NO REPORTS OF DELAY TO A PLANNED SURGICAL PROCEDURE. A SPARE IDENTICAL DEVICE WAS AVAILABLE FOR USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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
    371167 CASING FOR 12V BATTERY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 007377

    Patients

    Seq Age Sex Outcome Treatment
    1