BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0 CM SHORT ATTACHMENT

    MDR report key: 3955396 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-13551
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    December 21, 2011
    Report Date
    December 21, 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
    NOT APPLICABLE

    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. DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT THE DEVICE WAS FOUND TO HAVE DAMAGE TO THE BEARINGS AND DRIED DETERGENT RESIDUE ON INTERNAL SURFACES, INDICATIVE OF IMPROPER CLEANING. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM USA STATING THE DEVICE OVERHEATED DURING SURGERY. NO INJURY OR MED INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653887 5.0 CM SHORT ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1