BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER SUCKER SHORT (BX/20)

    MDR report key: 3984172 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-14210
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    August 17, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    KDC
    PMA / PMN Number
    K822065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF#: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE HAS A S"DEBRIS IN STERILE PACKAGE" ISSUE. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF THERE WAS ANY INJURY OR MEDICAL INTERVENTION WHICH OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664057 SUPER SUCKER SHORT (BX/20) KDC DEPUY SYNTHES POWER TOOLS E183048521

    Patients

    Seq Age Sex Outcome Treatment
    1