BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANIOTOME ATTACHMENT

    MDR report key: 3811241 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-04470
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT REC'D FROM (B)(6) STATING THAT THE DEVICE HAD A DAMAGED NEURO-TIP. IT IS UNK IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523972 6.5CM ADULT CRANIOTOME ATTACHMENT MOTOR, DRILL, ELECTRIC-CRANIOTOME, PRODUCT CODE: HBC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1