BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SAGITTAL SAW

    MDR report key: 2102541 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01816
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 28, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS REC'D AT THE MANUFACTURER FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION IT WAS FOUND THAT THE BLADE MOUNT IS CHIPPED. BASED ON THE INVESTIGATION DETAILS, SERVICE REPLACED THE BLADE MOUNT ASSEMBLY ALONG WITH OTHER COMPONENTS, AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    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 PT INVOLVEMENT DURING THIS EVENT AT THE MANUFACTURER. 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