BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM KIRSCHNER WIRE W/15MM THREAD-TROCAR POINT 150MM

    MDR report key: 7658886 · Received July 3, 2018

    Report

    Report Number
    8030965-2018-54785
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 6, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDW
    UDI-DI
    07611819320017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS NOTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. ADDITIONAL PROCODES: DZL, MQN. LOT NUMBER IS UNKNOWN. IT IS UNKNOWN IF DEVICES WERE IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER PHONE NUMBER AND EMAIL ADDRESS ARE UNKNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE SURGEON THAT DURING HIS RECENT PROCEDURE, THREE (3) 2.0MM K-WIRES BENT VERY EASILY. THERE WAS NO REPORTED PATIENT IMPACT OR DELAY. THIS HAS BEEN A REPEATING OCCURRENCE AND THE SURGEON IS UNSURE OF THE TOTAL QUANTITY OF BENT K-WIRES. THIS REPORT IS FOR A 2.0MM KIRSCHNER WIRE W/15MM THREAD-TROCAR POINT 150MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500952 2.0MM KIRSCHNER WIRE W/15MM THREAD-TROCAR POINT 150MM PIN, FIXATION, THREADED JDW OBERDORF SYNTHES PRODUKTIONS GMBH 07611819320017

    Patients

    Seq Age Sex Outcome Treatment
    1