BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMT

    MDR report key: 4171081 · Received October 14, 2014

    Report

    Report Number
    1045834-2014-13295
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    May 27, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK133604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE NEURO TIP WAS NOT FUNCTIONING. THIS WAS ATTRIBUTED TO FAULTY HANDLING. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE, THE TECHNICIAN FOUND THAT THE CRANI HANDLE WAS DEFORMED. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650991 6.5CM ADULT CRANI ATTACHMT MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1