BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6806982 · Received August 21, 2017

    Report

    Report Number
    3009450863-2017-10025
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    July 27, 2017
    Report Date
    July 27, 2017
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    MQN
    PMA / PMN Number
    K050378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. ADDITIONAL PRODUCT CODES: DZL, MQN. UDI: (B)(4) LOT UNKNOWN. DEVICE BROKEN DURING INSERTION; DEVICE NOT CONSIDERED IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS IT WAS REPORTEDLY DISCARDED. PHONE NUMBER: (B)(6). 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 THAT THE K-WIRE BROKE DURING A SURGERY. NO PATIENT HARM WAS REPORTED; THE PATIENT OUTCOME WAS REPORTED AS NORMAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED, AND WERE NOT REMOVED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO PROLONGATION OF THE SURGERY REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587653 2.0MM KIRSCHNER WIRE W/15MM THREAD-TROCAR POINT 150MM PIN, FIXATION, THREADED MQN SYNTHES BALSTHAL

    Patients

    Seq Age Sex Outcome Treatment
    1