BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3102965 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02484
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS THE ELECTRIC PEN DRIVE OVERHEATED DURING AN UNKNOWN SURGICAL PROCEDURE. IT IS REPORTED THERE WAS NO DELAY IN PROCEDURE AS THERE WERE THREE DEVICES WERE AVAILABLE FOR USE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203045 ELECTRIC PEN DRIVE 60,000 RPM HWE SYNTHES USA 2295

    Patients

    Seq Age Sex Outcome Treatment
    1