BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER W/HUDSON END

    MDR report key: 3984320 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16085
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    July 17, 2012
    Report Date
    July 17, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROGRESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL 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 NEEDED TO BE SERVICED. DURING SERVICING, IT WAS FOUND THAT THE DEVICE HAD A DAMAGED COMPONENT - DRIVE SHAFT BENT. IT IS UNK IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNK IF THERE WERE ANY PATIENT OR USER INJURIES THAT OCCURRED. THERE WAS ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663921 PERFORATOR DRIVER W/HUDSON END HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1