BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT

    MDR report key: 3132297 · Received May 29, 2013

    Report

    Report Number
    0001811755-2013-01221
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF OVERHEATING WAS DUPLICATED BY THE QUALITY SPECIALIST THROUGH FUNCTIONAL EVALUATION. THE APPEARANCE OF CORROSION WAS OBSERVED IN THE FIELD AND UPON DISASSEMBLY, A LACK OF LUBRICATION WAS FOUND TO BE AFFECTING THE BEARING IN THE UPPER ASSEMBLY. THE PRESENCE OF CORROSION AND A LACK OF LUBRICATION IS LIKELY TO CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE DEVICE WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE DEVICE WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236514 CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1