BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ SYRINGE KIT

    MDR report key: 8387978 · Received March 4, 2019

    Report

    Report Number
    8030965-2019-61711
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 11, 2019
    Report Date
    February 11, 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

    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. H3, H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 03.702.215S, LOT: 8102588. MANUFACTURING LOCATION: SELZACH, RELEASE TO WAREHOUSE DATE: DEC 16, 2018, EXPIRY DATE: OCT 01, 2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. H3, H6: COMPLAINT IS CONFIRMED BASED ON THE PROVIDED PHOTOGRAPHS. IT IS VISIBLE THAT THE TIP OF THE SYRINGE IS MISSING/BROKEN. H11 CORRECTION DATA: E1: REPORTER FACILITY COUNTRY CODE AND PHONE NUMBER. E1: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. 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 FURTHER REPORTED THE SURGEON USED THE OTHER SYRINGES ON THE SET TO SUCCESSFULLY COMPLETE PROCEDURE.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; 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, THE TIP OF THE WHITE VERTECEM SYRINGE KIT BROKE WHILE REMOVING FROM CEMENT RESERVOIR (VERCETEM V+ CEMENT KIT) DURING AN UNKNOWN PROCEDURE. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED ALTHOUGH IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. THERE WERE NO SURGICAL DELAY AND PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: VERCETEM V+CEMENT KIT (PART# 07.702.016S, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180025 VERTECEM V+ SYRINGE KIT CEMENT DISPENSER OAR OBERDORF SYNTHES PRODUKTIONS GMBH 8102588 07611819396074

    Patients

    Seq Age Sex Outcome Treatment
    1