BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11 CM ANGLE ATTACHMENT QD11

    MDR report key: 4180696 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-13732
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    August 21, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4). DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, IT WAS NOTICED THAT THE DEVICE FAILED THE TEMPERATURE TESTING.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR INSPECTION. DURING THE EVALUATION, THE TECHNICIAN REPORTED THE TOOL COULD NOT BE USED, AS THE EXTENSION CONNECTION WAS HEAVILY DAMAGED. THE GROUTING OF THE BEVEL WHEELS WAS INSUFFICIENT. THE BALL BEARINGS IN THE EXTENSION CONNECTION WERE DAMAGED. THIS WAS ATTRIBUTED TO NORMAL WEAR. VARIOUS PARTS WERE REPLACED. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    THE DEVICE RETURN FOR SERVICE DUE TO OVERHEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662980 11 CM ANGLE ATTACHMENT QD11 MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1