BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RCIP/STERNUM SAW

    MDR report key: 2132313 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02127
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 24, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR SERVICE AND EVAL. DURING THE INVESTIGATION, A RUN-ON CONDITION WAS FOUND. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS THE ANTI-ROTATIONAL PIN FELL OUT, WHICH ATTACHED TO THE TRIGGER MAGNET. THE PIN THEN LODGED ITSELF BETWEEN THE TRIGGER MAGNET AND HOUSING, AND THAT EFFECTIVELY CAUSED THE RUN-ON.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MFR 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 AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RCIP/STERNUM SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK