BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC+F/PINS Ø1.5-4

    MDR report key: 4182167 · Received October 17, 2014

    Report

    Report Number
    3009450871-2014-10506
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 13, 2013
    Report Date
    September 3, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE WAS UNKNOWN. THEREFORE, THE DEVICE MANUFACTURE DATE WAS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING A BILATERAL TOTAL KNEE ARTHROPLASTY, IT WAS OBSERVED THAT THE BATTERY OSCILLATOR DEVICE DID NOT HAVE ENOUGH POWER. IT WAS FURTHER REPORTED THAT THERE WAS AN INSUFFICIENT EASE OF INSERTING AND REMOVING PINS ON THE PIN DRIVER DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THE PIN DRIVER DEVICE HAD INSUFFICIENT LEVER FUNCTION. THE REPORTER STATED THERE WAS ALSO AN INSUFFICIENT EASE OF INSERTING AND REMOVING WIRES ON THE WIRE DRIVER DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THE WIRE DRIVER DEVICE HAD INSUFFICIENT LEVER FUNCTION. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    662087 QC+F/PINS Ø1.5-4 MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY OSCILLATOR DEVICE| PIN DRIVER DEVICE