BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER W/HUDSON END

    MDR report key: 3955331 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-13082
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    June 29, 2011
    Report Date
    July 5, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED PROBLEM OF "OVERHEATING" COULD NOT BE CONFIRMED. THE DEVICE PASSED ALL TESTS AND NO FAILURES WERE OBSERVED. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE OVERHEATED DURING SURGERY. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653752 PERFORATOR DRIVER W/HUDSON END HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1