BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.00 CM MEDIUM ATTACHMENT

    MDR report key: 3984289 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16359
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    June 28, 2011
    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 INVESTIGATION IS STILL IN PROGRESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE NEEDED SERVICE. DURING SERVICING THE DEVICE WAS FOUND TO HAVE COSMETIC DEFECT. IT IS UNK IF THE DEVICE WAS USED DURING SURGERY. IT IS ALSO UNK IF HERE WERE ANY INJURIES, MEDICAL INTERVENTION OR SURGICAL DELAY RELATED TO THE EVENT. THE DATE OF THE EVENT IS UNK. NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664397 8.00 CM MEDIUM ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1