BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER W/HUDSON END

    MDR report key: 3984166 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-03893
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLSTHE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION OF VIBRATION COULD NOT BE CONFIRMED OR DUPLICATED; THE UNIT WAS TESTED WITH SEVERAL DIFFERENT MOTORS, AND NO VIBRATION COULD BE DETECTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS VIBRATING DURING SURGERY. NO INJURIES WERE REPORTED TO HAVE OCCURRED, HOWEVER, IT IS UNKNOWN IF MEDICAL INTERVENTION WAS NECESSARY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664056 PERFORATOR DRIVER W/HUDSON END HBE DEPUY SYNTHES POWER TOOLSTHE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NI