BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 RECIPROCATING SAW

    MDR report key: 2082530 · Received April 28, 2011

    Report

    Report Number
    1811755-2011-01450
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND THE EVENT WAS CONFIRMED. THE HANDPIECE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DECORATIVE SCREW WAS MISSING AND THE HANDPIECE WAS SEPARATING DURING SET UP FOR A PROCEDURE. THE CUSTOMER PULLED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 5 RECIPROCATING SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK