BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.5CM ANGLE ATTACHMENT

    MDR report key: 4170571 · Received October 14, 2014

    Report

    Report Number
    1045834-2014-14034
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    December 14, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE RETURNED FOR SERVICE. THE ROOT CAUSE IS UNDETERMINED. NO ADDITIONAL INFORMATION AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ATTACHMENT HEATED UP DURING USE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651713 7.5CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1