BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT CRANIOTOME

    MDR report key: 4171072 · Received October 14, 2014

    Report

    Report Number
    1045834-2014-13792
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    March 12, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK133604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE DEVICE EXPERIENCED A PROBLEM WHEN THE REAMER WAS ASSEMBLED. AN ASSIGNABLE ROOT CAUSE IS UNDETERMINED. THE DEVICE WAS EXCHANGED AND THE REPLACEMENT SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE HAD PROBLEMS WHEN THE REAMER WAS ASSEMBLED. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650849 ADULT CRANIOTOME MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1