BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORIAN DRILLABLE INJECT 5CC-STERILE

    MDR report key: 6155792 · Received December 8, 2016

    Report

    Report Number
    2520274-2016-15633
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 15, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    MQV
    PMA / PMN Number
    K102722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). LOT NUMBER UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT IS REPORTED DURING A COMPLEX HUMERAL FRACTURE PROCEDURE ON (B)(6) 2016, PATIENT WAS INJECTED WITH AN EXPIRED PRODUCT. SURGEON WAS HOLDING THE REDUCTION OF THE FRACTURE AND REQUESTED NORIAN DRILLABLE INJECTABLE. A 5CC SIZE OF THE PRODUCT WAS RETRIEVED AND MIXED BUT WAS NOT USED DUE TO A MIXING ERROR. THE PRODUCT WAS NOT ROLLED OUT OF THE POUCH AND INTO THE SYRINGE. THE ERROR WAS NOTED WHEN THE STERILE SYRINGE WAS PARTIALLY OPENED. A 3CC SIZE OF THE PRODUCT WAS THEN RETRIEVED, MIXED, AND INJECTED INTO THE PATIENT¿S FRACTURE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO FURTHER HARM TO PATIENT. THIS ISSUE WAS NOTICED AFTER THE PROCEDURE WHILE COMPLETING THE SURGERY PAPERWORK, IT WAS NOTED THE INJECTABLE USED HAD EXPIRED AUGUST 31, 2016. THIS IS REPORT NUMBER 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805891 NORIAN DRILLABLE INJECT 5CC-STERILE N/A MQV SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1