BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE, FIXATION, INTRAOSSEOUS

    MDR report key: 3667848 · Received March 7, 2014

    Report

    Report Number
    2520274-2014-10173
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    January 28, 2014
    Report Date
    February 6, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2014 A PROXIMAL FEMORAL NAIL ANTIROTATION WAS USED FOR AN INTERTROCHANTERIC FEMORAL FRACTURE CASE. AFTER SEVERAL CHECKS OF THE DEVICE BY ASSEMBLING WITH NAIL BEFORE IMPLANTATION, THE NAIL WAS INSERTED. AFTER THAT, WHEN THE GUIDE WIRE WAS INSERTED IT THEN INTERFERED WITH THE NAIL. THE SURGEON TRIED TO INSERT THE GUIDE WIRE AGAIN, BUT THE SITUATION DID NOT CHANGE. THE SURGEON REMOVED THE NAIL AND DID SEVERAL DRY CHECKS AGAIN. IT WAS REPORTED THAT THE NAIL WENT INTO THE ERRATIC POSITION AGAINST THE NAIL HOLE. AT THAT POINT, A NEW GUIDE WIRE WAS REPLACED. AFTER THAT, THE OPERATION WAS COMPLETED AS PER THE NORMAL PROCEDURE AND WITHOUT ANY ADDITIONAL PROBLEMS. THERE WAS A FIFTEEN MINUTE SURGICAL DELAY REPORTED. THIS COMPLAINT IS FOR 3 OF 3 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139182 WIRE, FIXATION, INTRAOSSEOUS DZK SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1