BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER DRIVE

    MDR report key: 3183393 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03610
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    February 1, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT. THE ADDITIONAL EVALUATION REVEALED THAT PER THE ADVERSE INCIDENT REPORT, THE OVERHEATING IS NOT A CONSEQUENCE OF THE TOOL BEING FAULTY, BUT AS A RESULT OF BEING USED FOR UNSUITABLE APPLICATIONS OVER A LONG PERIOD OF TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MACHINE OVERHEATED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283239 POWER DRIVE GEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1