BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER DRIVE

    MDR report key: 3102990 · Received May 9, 2013

    Report

    Report Number
    8030965-2013-02158
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    REPORTEDLY THE POWER DRIVE OVERHEATED DURING A SURGICAL PROCEDURE ON (B)(6) 2013. IT IS REPORTED SURGEON USED THE DEVICE TO COMPLETE THE PROCEDURE. SURGEON LATER STATED THE DEVICE WOULD NOT START DURING PRE-TESTING. SURGEON REPORTED THERE WERE THREE DEVICES AVAILABLE FOR USE, BUT WAS UNABLE TO DETERMINE WHICH DEVICE WAS USED DURING THE PROCEDURE. NOT ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203711 POWER DRIVE GEY SYNTHES GMBH 01836

    Patients

    Seq Age Sex Outcome Treatment
    1