BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SAGITTAL SAW

    MDR report key: 2102508 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01814
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 26, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THIS CAN OCCUR IF NON-MANUFACTURER BLADES ARE USED WITH THE HANDPIECE OR IF THE BLADE WAS NOT PROPERLY SEATED IN THE HANDPIECE. 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 DEVICE'S BLADE MOUNT IS CHIPPED. THERE WAS NO PT INVOLVEMENT DURING THIS PARTICULAR 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