BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 2102507 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01819
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS REC'D AT THE MANUFACTURER FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION A RUN-ON CONDITION WAS FOUND AND THEN REPORTED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH E-BOX, WHICH WAS REPLACED ALONG WITH BEARINGS, WIRING, AND OTHER COMPONENTS. SERVICE DID A CLEAN, LUBE, AND ADJUST TO THE DEVICE, AND IT 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 THE DEVICE CONTINUED TO RUN ON ITS OWN. 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 6 SAGITTAL SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK