BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 2524740 · Received March 29, 2012

    Report

    Report Number
    1811755-2012-01148
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 13, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INITIAL CORRECTIVE ACTION HAS TAKEN PLACE. THIS ISSUE HAS OCCURRED PREDOMINATELY IN (B)(6). AN EXTENSIVE INVESTIGATION CONDUCTED BY STRYKER INSTRUMENTS HAS DETERMINED THAT THE ROOT CAUSE OF THIS ISSUE IS RELATED TO THE RIGOROUS REPROCESSING METHODS USED IN (B)(6). THE (B)(6) GOVERNMENT SENDS OUT A CIRCULAR THAT RECOMMENDS THE HOUSING BE STERILIZED FOR 18 MINUTES AT 134 DEGREES C. MFR INVESTIGATIVE TESTING INDICATES THE DEVICES IN THESE COMPLAINTS WERE NOT LASTING THE EXPECTED LIFE DUE TO THE COMBINATION OF CHEMICALS AND TIME EXPOSED TO HIGH HEAT. THE IFU FOR THIS PRODUCT RECOMMENDS 4 MINUTE EXPOSURE TIME AT 132-134 DEGREES C.; THEREFORE, THE REPROCESSING METHODS USED IN (B)(6) ARE NOT IN LINE WITH THE IFU. THE ROOT CAUSE FOR THESE TYPES OF CUSTOMER COMPLAINTS IS RELATED TO USER ERROR (I.E., FAILURE TO FOLLOW INSTRUCTIONS CONTAINED WITHIN THE IFU). STRYKER INSTRUMENTS HAS NOT RECEIVED ANY COMPLAINTS OF THIS NATURE IN WHICH IT IS ALLEGED THAT A SERIOUS INJURY HAS OCCURRED. THE PROBABILITY OF ACTUAL SERIOUS INJURY IS REMOTE BASED ON ACTUAL COMPLAINT DATA AND ESTIMATED DEVICE USAGE. THE SITUATION CONTINUES TO BE MONITORED AND REMAINS UNDER INVESTIGATION WHILE ONGOING REGULAR DISCUSSIONS ARE OCCURRING WITH (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DELRIN BALL IN THE LOCKING MECHANISM OF THE ASEPTIC BATTERY HOUSING WAS MISSING. NOTHING FELL INTO A SURGICAL SITE, AS THIS WAS DETERMINED WHILE INSPECTING THE DEVICE. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 ASEPTIC HOUSING ASSY KIJ STRYKER INSTRUMENTS KALAMAZOO 08262

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK