BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD CRANIOTOME, BM

    MDR report key: 3983927 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-14329
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND EVALUATED BY DEPUY SYNTHES POWER TOOLS. THE REPORTED CONDITION OF "CAME APART" COULD NOT BE CONFIRMED. THE DEVICE PASSED ALL TESTS AND NO PROBLEMS WERE OBSERVED. IF ADD'L 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 "AME APART." IT IS KNOWN THAT THE DEVICE WAS BEING USED DURING SURGERY. THERE WAS NO PT OR USER INJURIES. IT IS UNK IF THERE WAS MEDICAL INTERVENTION RELATED TO THE EVENT. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663105 STD CRANIOTOME, BM GFF DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1