BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11 CM ANGLE ATTACHMENT QD11

    MDR report key: 4180694 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14415
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    April 12, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE CONTROL UNIT DID NOT OPERATE. THIS WAS ATTRIBUTED TO NORMAL WEAR. VARIOUS PARTS WERE REPLACED. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    COMPLAINT; ATTACHMENT HEATS UP. DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE, TECHNICIAN FOUND THE FRONT BEARING BROKEN AND THE GUIDE TUBE ENLARGED. TECHNICIAN REPLACED FRONT BEARING AND GUIDE TUBE. THIS IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662543 11 CM ANGLE ATTACHMENT QD11 MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1