BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMA SYRING KIT 4*1 ML 2*2 ML

    MDR report key: 10508595 · Received September 9, 2020

    Report

    Report Number
    2939274-2020-04054
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Report Date
    August 12, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KIH
    UDI-DI
    10886982262233
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: B5 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 REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE TRAUMACEM V+ INJECTION CANNULA AND TRAUMACEM V+ SYRINGE KIT WOULD NOT INJECT INTO SYRINGES ONCE MIXED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PART: 03.702.150S, LOT: 8042526, MANUFACTURING SITE: SELZACH, SUPPLIER: SYMATESE DEVICE, RELEASE TO WAREHOUSE DATE: 05.JUN.2018, EXPIRY DATE: 31.MAR.2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020 THE TRAUMACEM V+ INJECTION CANNULA AND TRAUMACEM V+ SYRINGE KIT WOULD NOT INJECT INTO SYRINGES. IT WAS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TRAUMA SYRINGE KIT 4*1 ML 2*2 ML. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976665 TRAUMA SYRING KIT 4*1 ML 2*2 ML DISPENSER, CEMENT KIH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.702.150S 8042526 10886982262233

    Patients

    Seq Age Sex Outcome Treatment
    1