BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.4CM HEAVY DUTY LONG ATTCH

    MDR report key: 3252957 · Received July 29, 2013

    Report

    Report Number
    1045834-2013-03721
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    September 28, 2011
    Report Date
    October 6, 2011
    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 WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF OVERHEATING WAS CONFIRMED. (B)(4) EVALUATED THE DEVICE, AND THE REPORTED HEAT WAS CONFIRMED; THE ATTACHMENT WAS TESTED AND FOUND TO EXCEED TEMPERATURE SPECIFICATIONS. IT WAS CONCLUDED THAT THE HEAT WAS CAUSED BY WORN/DAMAGED BEARINGS. THE DEVICE WAS DISASSEMBLED, AND DRIED BIOLOGICAL DEBRIS WAS OBSERVED COATING THE BEARINGS OF THE ATTACHMENTS. IT'S LIKELY THE FRICTION CREATED BY THE PRESENCE OF THE DEBRIS CONTRIBUTED TO THE REPORTED HEAT. THIS CONDITION IS INDICATIVE OF IMPROPER OR INEFFECTIVE CLEANING AND MAINTENANCE OF THE DEVICES. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS OVERHEATING. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352255 12.4CM HEAVY DUTY LONG ATTCH MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1