BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMACEM(TM) V+ SYRINGE KIT - STERILE

    MDR report key: 12565366 · Received October 1, 2021

    Report

    Report Number
    8030965-2021-08304
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 4, 2021
    Report Date
    September 4, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KIH
    UDI-DI
    07611819476523
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.702.150S, LOT: 0012735, MANUFACTURING SITE: (B)(4), SUPPLIER: SYMATESE DEVICE, RELEASE TO WAREHOUSE DATE: 03 FEBRUARY 2020, EXPIRATION DATE: 01 FEBRUARY 2025, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A PROCEDURE WHEN PREPARING THE CEMENT FOR USE, AFTER MIXING WE WERE UNABLE TO FILL THE SYRINGES AS THE CEMENT WAS UNABLE TO COME THROUGH. ALL STEPS WERE CORRECTLY FOLLOWED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BUT WITHOUT THE USE OF AUGMENTATION. THERE WAS NO DELAY AND NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) TRAUMACEM(TM) V+ SYRINGE KIT - STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462152 TRAUMACEM(TM) V+ SYRINGE KIT - STERILE DISPENSER, CEMENT KIH SYNTHES GMBH 0012735 07611819476523

    Patients

    Seq Age Sex Outcome Treatment
    1