BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT

    MDR report key: 3811889 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-07737
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4). NO FILES ATTACHED.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THEY COULD NOT REMOVE THE CUTTER FROM THE DEVICE. IT WAS REPORTED THAT THE DEVICE WAS BEING USED IN SURGERY WITH NO PATIENT OR USER INJURY. IT IS UNKNOWN IF MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523796 11CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1