BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5CM HEAVY DUTY SHORT ATTACH

    MDR report key: 3811863 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-05234
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    July 9, 2012
    Report Date
    July 10, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED DEPUY SYNTHES POWER TOOLS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4). NO FILES ATTACHED.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED THE DEVICE HAS EXPERIENCED A "DOES NOT FUNCTION" ISSUE DURING SURGERY. NO PATIENT OR USER INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524362 5CM HEAVY DUTY SHORT ATTACH MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly