BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5CM HEAVY DUTY SHORT ATTACHMENT

    MDR report key: 3983926 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-10113
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED, AND DURING SERVICE THE DEVICE FAILED THE TEMPERATURE TEST. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE HAD OVERHEATED. THE DEVICE WAS NOT BEING USED DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION PROVIDED. THE DATE OF EVENT WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663699 5CM HEAVY DUTY SHORT ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1