BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLIFE LARGE BATTERY

    MDR report key: 3843410 · Received June 2, 2014

    Report

    Report Number
    0001811755-2014-02011
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED BY THE TECHNICIAN THROUGH VISUAL INSPECTION. THE BATTERY HOUSING WAS CRACKED/DAMAGED. IT IS POSSIBLE THAT THE DAMAGE OCCURRED DUE TO EXCESSIVE SIDELOAD. THE BATTERY WAS PLACED IN PARTS RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 BATTERY WAS BROKEN IN HALF WHEN RECEIVED AT THE MANUFACTURER FACILITY. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYTEM 7 BATTERY WAS BROKEN IN HALF WHEN RECEIVED AT THE MANUFACTURER FACILITY. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321120 SMARTLIFE LARGE BATTERY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1