BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SAGITTAL SAW

    MDR report key: 2241635 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03215
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION, IT WAS FOUND THAT THE BLADE MOUNT IS CHIPPED. THERE WAS ALSO DEBRIS PRESENT IN THE BLADE MOUNT. BASED ON THE INVESTIGATION DETAILS, THIS CAN OCCUR IF NON-MANUFACTURER BLADES ARE USED WITH THE 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 MANUFACTURER FOR SERVICE, AND DURING THE INVESTIGATION, IT WAS FOUND THAT THE BLADE MOUNT IS CHIPPED. THERE WAS NO PATIENT 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 SAGITTAL SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK