BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ SYRINGE KIT

    MDR report key: 12616042 · Received October 12, 2021

    Report

    Report Number
    8030965-2021-08610
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 14, 2021
    Report Date
    September 14, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    UDI-DI
    07611819396074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: H3, H4, H6- VISUAL ANALYSIS OF THE PHOTO REVEALED THAT VERTECEM V+ SYRINGE KIT CEMENT HAS BEEN SOLIDIFIED IN THE STOPCOCK AND FOUND THAT THE RING-SHAPED RUBBER PACKING OF THE LID HAS FALLEN OFF. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR VERTECEM V+ SYRINGE KIT. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT ==> PART: 03.702.215S. LOT: 1012516. MANUFACTURING SITE: SELZACH. SUPPLIER: SYMATESE DEVICE. RELEASE TO WAREHOUSE DATE: 03 FEBRUARY 2021. EXPIRATION DATE: 01 FEBRUARY 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 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: INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO US CQ FOR EVALUATION. THE ONE-WAY STOP COCK WAS ONLY RETURNED FROM VERTECEM V+ SYRINGE KIT. THE US CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT CEMENT WAS HARDENED INSIDE THE STOCK COCK. THE RING-SHAPED RUBBER PACKING OF THE LID WAS RECEIVED SEPARATELY FROM THE STOCK COCK. HOWEVER, IT WAS SNAPPED INTO THE STOCK COCK AND FITS PERFECTLY WELL. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED FOR THE VERTECEM V+ SYRINGE KIT AS IT'S NOT PERTAINING TO THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR THE VERTECEM V+ SYRINGE KIT. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. CORRECTED DATA: D9, H3, H6.

    Additional Manufacturer Narrative · 0

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY (L1) FOR TREATING COMPRESSION FRACTURE DUE TO OSTEOPOROSIS ON (B)(6), 2021. AFTER THE CEMENT WAS MIXED UP, THE STAFF CHECKED THE MIXED CEMENT TO CONFIRM IT WAS READY FOR USE. THE AIR IN THE CEMENT MIXING DEVICE WAS SQUEEZED OUT. NEXT, THE 2-WAY CONNECTOR WAS MOUNTED HOWEVER, THE CEMENT DID NOT COME OUT. IT WAS CONFIRMED THAT THE CEMENT ON THE MIXER SIDE FLOWED BUT NOTHING CHANGED ON THE SYRINGE SIDE OF THE CONNECTOR. THE BLACK RUBBER RING LOCATED INSIDE THE CEMENT MIXERS CAP CAME OFF DURING TROUBLESHOOTING. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS AND REQUIRED LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512556 VERTECEM V+ SYRINGE KIT POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES GMBH 1012516 07611819396074

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL.