BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3646634 · Received February 26, 2014

    Report

    Report Number
    8030965-2014-00367
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 28, 2014
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DZI, ERL, HBE: ADDITIONAL CODES (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: MANUFACTURED IN 2006. THE PART WAS RETURNED AND INSPECTED. DURING THE INSPECTION THE TECHNICIAN FOUND THE COUPLING TOOL WAS SEIZED AND ROUGH RUNNING. THE NOTED OBSERVATIONS ARE DUE TO NORMAL WEAR. DEVICE REPAIRED AND RETURNED TO CUSTOMER. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THEREFORE NO SERVICE HISTORY REVIEW CAN BE PERFORMED. INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE IS NOT FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) SERVICE AND REPAIR REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE ELECTRIC PEN DRIVE HAS NO POWER WHEN ATTACHMENTS ARE INSERTED TO THE DEVICE. SENT IN FOR EVALUATION AND REPAIR. THIS HAPPENED DURING THE OPERATION. THEY PROCEEDED WITHOUT THE DEVICE. PATIENT NOT AFFECTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117790 ELECTRIC PEN DRIVE 60,000 RPM HWE SYNTHES GMBH 0832

    Patients

    Seq Age Sex Outcome Treatment
    1