BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER SUCKER SHORT, X50 BULK PACKED

    MDR report key: 4163659 · Received October 10, 2014

    Report

    Report Number
    1045834-2014-13133
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    February 1, 2014
    Report Date
    September 18, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    KDC
    PMA / PMN Number
    PK822065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. A VISUAL ASSESSMENT WAS PERFORMED WHICH CONFIRMED THAT THE FILTER LOCKING TAB WAS MISSING. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO THE TAB GETTING SNAGGED AND PULLED OFF DURING PROCESSING. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM CANADA THAT DURING A TOTAL HIP SURGERY, IT WAS OBSERVED THAT THE TAB WAS BROKEN ON THE SUCTION NOZZLE OF THE SUPER SUCKER DEVICE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE REPORTED STATED THAT THE EVENT OCCURRED DURING THE MONTH OF (B)(6) 2014; HOWEVER, THE EXACT DATE OF THE EVENT WAS UNKNOWN. THE REPORTER STATED THAT THE DEVICE WAS USED IN A CANADIAN FACILITY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639272 SUPER SUCKER SHORT, X50 BULK PACKED INSTRUMENT, SURGICAL, DISPOSABLE - SUCTION TIP KDC DEPUY SYNTHES POWER TOOLS G483087436

    Patients

    Seq Age Sex Outcome Treatment
    1