BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SMALL BATTERY

    MDR report key: 1842000 · Received August 26, 2010

    Report

    Report Number
    1811755-2010-01013
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 3, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE PRODUCT WAS REQUESTED FROM THE ACCOUNT ON (B)(4) 2010 AND (B)(4) 2010. THIS REPORT WILL BE UPDATED WHEN THE PRODUCT IS RETURNED AND AN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE HAVING ISSUES KEEPING THEIR BATTERIES CHARGED AND IT CAUSED AN ISSUE IN SEVERAL SURGERIES. IT WAS REPORTED THAT DURING AT LEAST 3 JOINT PROCEDURES FIVE BATTERIES WERE GONE THROUGH BEFORE A CHARGED ONE WAS FOUND. EVENTS SURROUNDING OTHER PROCEDURES WERE UNK. THE ACCOUNT WOULD USE AN OLDER BACKUP SYSTEM TO COMPLETE THE PROCEDURE. THIS DELAYED THE SURGERIES 30 MINS. THERE WERE NO ADVERSE CONSEQUENCES DURING THESE INCIDENCES AND THEY WERE ALL COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 SMALL BATTERY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK