BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 2974324 · Received February 22, 2013

    Report

    Report Number
    0001811755-2013-00361
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 11, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE. THE

    Additional Manufacturer Narrative · 1

    THE BATTERY HOUSING WAS CONFIRMED TO BE MISSING THE DELRIN BALL CAUSING THE LATCH OF THE BATTERY HOUSING TO NOT PROPERLY LOCK IN PLACE. BASED ON SIMILAR COMPLAINTS, POSSIBLE CAUSES INCLUDE NORMAL WEAR AND TEAR OR MECHANICAL DAMAGE THAT CAUSED THE BALL TO SHATTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 6 ASEPTIC BATTERY HOUSING OPENED DURING A PROCEDURE. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 6 ASEPTIC BATTERY HOUSING OPENED DURING A PROCEDURE. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77751 SYSTEM 6 ASEPTIC HOUSING ASSY INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO 11344

    Patients

    Seq Age Sex Outcome Treatment
    1