BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR K-WIRES

    MDR report key: 3760252 · Received April 19, 2014

    Report

    Report Number
    8030965-2014-10161
    Event Type
    Malfunction
    Date Received
    April 19, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. A FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE DEVICE WHICH FOUND A WORN CHUCK. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE MOST LIKELY DUE TO NORMAL WEAR OVER TIME. 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

    IT WAS REPORTED THAT DURING A TIBIAL PLATEAU LEVELING OSTEOTOMY (TPLO) SURGICAL PROCEDURE ON A CANINE, IT WAS DISCOVERED THAT THE QUICK COUPLING FOR K-WIRES DEVICE WAS MAKING GRINDING NOISE AND SLOWING DOWN. THERE WAS A THREE MINUTE DELAY IN SURGERY. THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WERE NO REPORTS OF PATIENT OR USER INJURIES. 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
    239091 QUICK COUPLING FOR K-WIRES INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 5183

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR