BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 4214097 · Received October 30, 2014

    Report

    Report Number
    2520274-2014-14437
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN NAIL. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.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 THE DURING INSERTION OF A GUIDE WIRE BEFORE USING SCREW, THE GUIDE WIRE WAS INTERFERED WITH A SCREW HOLE OF NAIL. THE SURGEON SOMEHOW INSERTED THE GUIDE WIRE AND COULD INSERT HIP SCREW AT THE DISTAL PART. A GUIDE WIRE WAS INTERFERED WITH THE NAIL ALSO AT THE PROXIMAL PART. SO, THE SURGEON DECIDED TO NOT INSERT THE SCREW AT THE PROXIMAL PART AND COMPLETE THE PROCEDURE. THERE WAS A REPORT OF A TEN MINUTE SURGICAL DELAY. THIS REPORT IS FOR AN UNKNOWN NAIL. THIS REPORT IS 5 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695894 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR