BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 3957594 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14743
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    June 30, 2011
    Manufacturer
    DEP[UY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    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 OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    DEVICE RECEIVED FROM SWITZERLAND FOR SERVICING. DURING SERVICING, IT WAS FOUND THAT THE DEVICE HAD DAMAGED BEARINGS. IT IS UNKNOWN IF THE DEVICE WAS USED DURING SURGERY. IT IS UNKNOWN IF INJURY, MEDICAL INTERVENTION, OR SURGICAL DELAY OCCURRED. THE DATE OF EVENT IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654309 5.0CM SHORT ATTACHMENT HBC DEP[UY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1