BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAL ACCESS ATTACHMENT

    MDR report key: 3970090 · Received December 11, 2013

    Report

    Report Number
    1045834-2013-14555
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    DEVICE RECEIVED FROM (B)(6) FOR SERVICE. DURING SERVICING OF THE DEVICE, IT WAS FOUND TO BE OVERHEATING. IT IS KNOWN THAT THE DEVICE WAS NOT USED IN SURGERY. THERE WAS NO PT OR USER INJURY REPORTED. THERE WAS NO MEDICAL INTERVENTION REPORTED. NO ADD'L INFO SHOULD BECOME AVAILABLE, THIS NOTIFICATION WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648314 MINIMAL ACCESS ATTACHMENT HBE DEPUY SYNTHES POWER TOOLS `

    Patients

    Seq Age Sex Outcome Treatment
    1