BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3242786 · Received July 23, 2013

    Report

    Report Number
    8030965-2013-04461
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 27, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT WAS REPORTED AS AN UNKNOWN DATE IN 2013. ADDITIONAL PRODUCT CODE(S): DZI, ERL, HBE. 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 (DHR) HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MANUFACTURER ON 7/12/2013. INVESTIGATION COORDINATED BY (B)(4). THE CUSTOMER'S COMPLAINT THAT THE DEVICE DOES NOT FUNCTION PROPERLY WAS CONFIRMED. A FUNCTIONAL ASSESSMENT WAS PERFORMED WHICH CONFIRMED THAT THE MOTOR WAS DAMAGED. IT WAS REPORTED THAT IT WAS DUE TO IMMERSION DURING CLEANING.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTED AN EVENT AS FOLLOWS: PEN DRIVE WOULD NOT RUN AT A STEADY SPEED. NO FURTHER INFORMATION WAS PROVIDED. 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
    343457 ELECTRIC PEN DRIVE 60,000 RPM HWE SYNTHES GMBH 3507

    Patients

    Seq Age Sex Outcome Treatment
    1