BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMT

    MDR report key: 3811268 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-13982
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Report Date
    June 8, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROGRESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF (B)(4).

    Description of Event or Problem · 1

    A REPORT FROM (B)(6) STATED THE DEVICE IS EXPERIENCING A DAMAGED "NEURO TIP" ISSUE. IT IS UNKNOWN IF THE DEVICE WAS USED IN SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION WERE REPORTED. THE DATE OF THE EVENT IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524004 6.5CM ADULT CRANI ATTACHMT MOTOR, DRILL, ELECTRIC - CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1