BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER SUCKER SHORT (BX/20)

    MDR report key: 3983801 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-12551
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    March 14, 2012
    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 WAS 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. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT 1 OF 31. REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE HAD DEBRIS IN THE STERILE PACKAGE. IT IS UNKNOWN IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION WERE REPORTED. THE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664052 SUPER SUCKER SHORT (BX/20) KDC DEPUY SYNTHES POWER TOOLS F023059360

    Patients

    Seq Age Sex Outcome Treatment
    1