BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER W/ HUDSON END

    MDR report key: 3955429 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-13557
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    February 9, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PROCESS. 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 USA STATING THAT THE DEVICE NEEDED TO BE SERVICED. DURING SERVICING, THE DEVICE WAS FOUND TO HAVE A BENT DRIVE SHAFT. IT IS UNK IF THE DEVICE WAS USED DURING SURGERY. IT IS ALSO UNK IF THERE WAS INJURY, MED INTERVENTION OR SURGICAL DELAY RELATED TO THE EVENT. THE DATE OF THE EVENT IS UNK. NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653893 PERFORATOR DRIVER W/ HUDSON END HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1