BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3132580 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02895
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE AS IT IS NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. MANUFACTURING EVALUATION REVIEWED, MDR REPORTABILITY STATUS UPDATED. THIS DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT # 2520274-2013-02895.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT IS UNKNOWN. 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 SURGICAL PROCEDURE ON AN UNKNOWN DATE, THE ELECTRICAL PEN DRIVE STOPPED WORKING. 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236637 ELECTRIC PEN DRIVE 60,000 RPM HWE SYNTHES (USA) 2891

    Patients

    Seq Age Sex Outcome Treatment
    1