BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SAGITTAL SAW

    MDR report key: 2130392 · Received May 9, 2011

    Report

    Report Number
    1811755-2011-01657
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL. DURING THE INVESTIGATION, IT WAS FOUND THAT THE BLADE MOUNT IS CHIPPED. BASED ON THE INVESTIGATION DETAILS, SERVICE AND MAINTENANCE WAS PERFORMED ON THE DEVICE. THE HANDPIECE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MFR FOR SERVICE, AND DURING THE INVESTIGATION, THE REPAIR TEAM FOUND THAT THE BLADE MOUNT IS CHIPPED. THERE WAS NO PT INVOLVEMENT DURING THIS EVENT. 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