BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3137939 · Received May 30, 2013

    Report

    Report Number
    8030965-2013-02414
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: DZI, ERL, HBE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A HAND SURGICAL PROCEDURE ON (B)(6) 2013; THE DEVICE WOULD ONLY WORK IN REVERSE AND HAD NO FORWARD CAPABILITY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR AN ELECTRIC PEN DRIVE 60,000 RPM. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240152 ELECTRIC PEN DRIVE 60,000 RPM HWE SYNTHES GMBH 3582

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR