BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SAGITAL SAW

    MDR report key: 2213825 · Received August 4, 2011

    Report

    Report Number
    1811755-2011-02789
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR SERVICE AND EVAL. DURING THE INVESTIGATION, IT WAS FOUND THAT THE BLADE MOUNT IS CHIPPED. BASED ON THE INVESTIGATION DETAILS, THIS CAN OCCUR IF NON-MFR BLADES ARE USED WITH THIS HANDPIECE OR IF THE BLADE WAS NOT PROPERLY SEATED IN THE HANDPIECE. THIS FAILURE COULD RENDER THE HANDPIECE USELESS DUE TO A LOOSE FITTING BLADE. IF THE HANDPIECE WAS OPERATED IN THIS FAILED CONDITION. IT MAY BE POSSIBLE THAT THE BLADE WOULD NOT CUT PROPERLY DUE TO THIS CHIP.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MFR FOR SERVICE, AND DURING THE INVESTIGATION IT WAS FOUND THAT THE BLADE MOUNT IS CHIPPED. THERE WAS NO PT INVOLVEMENT DURING THIS EVENT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 5 SAGITAL SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK