BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ SYRINGE KIT

    MDR report key: 8381867 · Received March 1, 2019

    Report

    Report Number
    8030965-2019-61625
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    February 6, 2019
    Report Date
    February 6, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    OAR
    UDI-DI
    07611819396074
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ADDITIONAL NARRATIVE: DEVICE HISTORY LOT. PART: 03.702.215S. LOT:8102588. MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 16 DEC 2018. EXPIRY DATE: 01.OCT 2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY PICTURE REVIEW DOES NOT ALLOW FOR A CONCLUSIVE STATEMENT CONCERNING COMPLAINT CONDITION. THREE SYRINGES OUT OF THE TWO MENTIONED VERTECEM V+ SYRINGE KITS WERE RETURNED BY CUSTOMER AND FORWARDED TO THE MANUFACTURER (SYMATESE DEVICE), WHERE THEY WERE CHECKED FOR CONFORMANCE TO THE SPECIFICATIONS. ABSTRACT FROM SUPPLIER'S REPORT: 3 SAMPLES OF 1ML SYRINGES HAVE BEEN RETURNED FOR INVESTIGATION. VISUAL INSPECTION SHOWED THAT THE LUER TIP OF THE SAMPLE 1 IS BROKEN, THE TWO OTHER ONES ARE DAMAGED. THE LUER THREADS AT THE BOTTOM OF THE 3 SAMPLES ARE DAMAGED WHICH COULD BE AN INDICATION THAT THE SCREWING HAS BEEN FORCED. THIS PRODUCTION LOT (8102588) WAS MANUFACTURED IN DECEMBER 2018 ACCORDING TO THE SPECIFICATION WITH NO NON-CONFORMITIES REPORTED NO ANOMALY OR DEVIATION IN RELATION WITH THE COMPLAINT, WAS REPORTED DURING THE MANUFACTURING OF THIS PRODUCTION LOT. ACCORDING TO THE PERFORMED INVESTIGATION AND THE SAMPLES ANALYSIS, THE POTENTIAL CAUSE IDENTIFIED IS DUE TO THE COMBINATION OF TWO EVENTS: SCREWING 'TOO HARD' TO THE BOTTOM OF THREADS INTERNAL DIAMETER OF THE STOPCOCK LUER AT THE MINIMAL DIMENSION - BUT STILL WITHIN TOLERANCE THE DESIGN OF THE SYRINGE CAN'T LIMIT SCREWING TORQUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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) 2019, DURING AN UNKNOWN PROCEDURE, TWO (2) VERTECEM SYRINGE KITS WERE BENT AND BROKEN AFTER REMOVING FROM THE VERTECEM CEMENT KIT RESERVOIR. IT WAS NOT POSSIBLE ANYMORE TO ATTACH THE SYRINGES TO THE STANDARD LUER NEEDLE SINCE THE TIP OF THE SYRINGE SCREW GOT BENT AND BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING OTHER SYRINGES THAT WERE STILL GOOD. NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN VERTECEM CEMENT KIT (PART # 07.702.016S, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175734 VERTECEM V+ SYRINGE KIT CEMENT DISPENSER OAR OBERDORF SYNTHES PRODUKTIONS GMBH 8102588 07611819396074

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE EVENT DESCRIPTION.