BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3454859 · Received November 7, 2013

    Report

    Report Number
    2520274-2013-07155
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Report Date
    October 10, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE HISTORY RECORD INDICATES THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION INDICATES THE REPORTERS COMPLAINT THAT THE UNIT WAS RUNNING HOT WAS CONFIRMED. THE DEVICE WAS TESTED AND THE COMPLAINT WAS DUPLICATED. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME ADDITIONAL CODES: DZI, ERL, HBE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(6). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTRIC PEN DRIVE WAS RUNNING HOT. PER ADDITIONAL INFORMATION THE INCIDENT WAS DISCOVERED DURING PRE-TESTING. NO PATIENT INVOLVEMENT. THIS IS COMPLAINT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577083 ELECTRIC PEN DRIVE 60,000 RPM HWE SYNTHES USA 0975

    Patients

    Seq Age Sex Outcome Treatment
    1