BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT

    MDR report key: 1972740 · Received January 21, 2011

    Report

    Report Number
    1811755-2011-00209
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR ON (B)(6) 2010, FOR SVC AND EVAL OF A MIDDLE BEARING. DURING THE REPAIR, A CONDITION OF THE DEVICE OVERHEATING WAS FOUND AND THEN REPORTED. BASED ON THE INVESTIGATION DETAILS, THE CAUSE WAS THE HIGH SPEED BUR ATTACHMENT, WHICH NEED TO BE REPLACED. THIS WAS REPLACED AND RETURNED ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPAIR OF A MIDDLE BEARING, THE HANDPIECE OVERHEATED. THERE WAS NO PT INVOLVEMENT, PT/USER INJURY, OR ADVERSE CONSEQUENCES WITH THIS EVENT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK