BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III

    MDR report key: 3160067 · Received June 10, 2013

    Report

    Report Number
    1045834-2013-02405
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 12, 2011
    Report Date
    June 28, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE COMPLAINT OF "BROKEN/CRACKED PSI GAUGE" WAS CONFIRMED. THE PRE-REPAIR ASSESSMENT FINDINGS SHOWED, "FOREIGN DEBRIS IN THE AUTOLUBE, CRACKED OIL FILL TUBE, AND OIL CONTAMINATION." IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE HAD A "CRACKED GAUGE." THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259625 AUTOLUBE-III MOTOR, SURGICAL INSTRUMENT - FOOT CONTROL GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1