BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3023739 · Received March 27, 2013

    Report

    Report Number
    8030965-2013-01156
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ADDITIONAL PRODUCT CODES: DZI, ERL, HBE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT ON (B)(6) 2013, DURING A PODIATRY PROCEDURE, THE ELECTRIC PEN DRIVE WAS MAKING A CLICKING NOISE. PROCEDURE WAS DELAYED APPROXIMATELY 15 MINUTES WHILE A BACK-UP DEVICE WAS PREPARED. PROCEDURE WAS COMPLETED USING THE BACK-UP DEVICE WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125896 ELECTRIC PEN DRIVE 60,000 RPM HWE SYNTHES GMBH 1266

    Patients

    Seq Age Sex Outcome Treatment
    1