BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORE RECIP SAW

    MDR report key: 1935150 · Received December 6, 2010

    Report

    Report Number
    1811755-2010-01917
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS CONFIRMED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH A WORN BUTTON AND SLIDE LOCK, BOTH OF WHICH WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE OVERHEATED DURING ROUTINE PREVENTATIVE MAINTENANCE TESTING BY THE MANUFACTURER. THIS DID NOT OCCUR DURING ANY SURGICAL OR MEDICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR CORE RECIP SAW SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENT DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK