BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR TPS SAG SAW

    MDR report key: 1851030 · Received September 27, 2010

    Report

    Report Number
    1811755-2010-01252
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVAL WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, DEBRIS WAS FOUND IN THE ROTOR. THE BEARINGS, MOTOR, AND PRESS PLUG WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE OVERHEATED DURING TESTING. THIS DID NOT OCCUR DURING ANY SURGICAL OR MEDICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR TPS SAG SAW BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK