BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO

    MDR report key: 3883534 · Received June 19, 2014

    Report

    Report Number
    2520274-2014-11965
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER LOCATION WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE LOCATION HAS BEEN UPDATED TO (B)(4). CONTACT OFFICE NAME/ADDRESS HAS BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECT MANUFACTURING FACILITY. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE DEVICE MANUFACTURE DATE HAS BEEN UPDATED AS OCT 30, 2012. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. THE DATE OF MANUFACTURE WAS UNKNOWN. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. 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 AFTER STERILE PROCESSING AT A VETERINARY FACILITY, IT WAS OBSERVED THAT THE BATTERY DEVICE WOULD NOT CHARGE. ACCORDING TO THE REPORT, THE DEVICE DISPLAYED A RED LIGHT WHEN THE DEVICE WAS PUT IN THE CHARGER. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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
    361197 SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 120829

    Patients

    Seq Age Sex Outcome Treatment
    1