BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR K-WIRES

    MDR report key: 3961609 · Received July 28, 2014

    Report

    Report Number
    8030965-2014-10420
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 13, 2014
    Report Date
    July 14, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE PASSED ALL MANUFACTURE'S SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. 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 AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE WAS NOT HOLDING WIRES AND THE INTERNAL JAWS WERE WORN. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS 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
    439740 QUICK COUPLING FOR K-WIRES INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 15521

    Patients

    Seq Age Sex Outcome Treatment
    1