BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYND-EZ TITANIUM

    MDR report key: 18527747 · Received January 17, 2024

    Report

    Report Number
    3007319107-2024-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 8, 2023
    Report Date
    February 28, 2024
    Manufacturer
    PARCUS MEDICAL LLC
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT.

    Additional Manufacturer Narrative · 0

    THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT. SUPPLEMENTAL REPORT: THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. THERE WAS A 30-MINUTE DELAY TO THE PROCEDURE, HOWEVER THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED BY THE COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE BATCH RECORD WAS PERFORMED. THERE WAS NO NONCONFORMANCES ASSOCIATED WITH THE MANUFACTURING OF THE PRODUCT IN THE MANUFACTURING RECORD. THE PRODUCT WAS MANUFACTURED AND RELEASED TO APPLICABLE PROCEDURES AND SPECIFICATIONS. A REVIEW OF THE LOAD TEST FOR THE PRODUCT WAS PERFORMED SHOWING ALL TESTED PARTS WERE BELOW THE MAX EXTENSION LIMITS. A THREE-YEAR RETROSPECTIVE REVIEW OF ALL NONCONFORMANCES WAS PERFORMED. THERE WAS NO NONCONFORMANCES ASSOCIATED WITH THIS PRODUCT. THE CASE WAS REVIEWED WITH ENGINEERING, THE PRODUCT IS ASSEMBLED BY LOOPING SUTURES THROUGH SPECIFIC HOLES WITHIN THE BUTTON AND TOP HAT PIECES THAT CAN BE TIGHTENED BY PULLING, THERE ARE NO KNOTS WITHIN THE ASSEMBLY. THIS SUGGESTS THAT THE TECHNIQUE OF THE SURGEON HAD CAUSE THE SUTURES TO BECOME TANGLED AND KNOTTED.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY PARCUS MEDICAL LLC OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, PARCUS MEDICAL LLC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON (B)(6) 2023 IT WAS REPORTED TO PARCUS MEDICAL LLC THAT THE ROPE SUTURES KNOTTED IN THE BONE TUNNEL WHICH PREVENTED TENSIONING ON A 41 YEAR OLD FEMALE PATIENT. THERE WAS A 30 MINUTE DELAY IN THE PROCURE. THERE WAS NO NEGATIVE PATIENT IMPACT. THERE WAS NO REPORT OF ANY APPEARANCE ISSUE WITH THE DEVICE OR PACKAGING PRIOR TO USE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION WAS SOLICITED.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY PARCUS MEDICAL LLC OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, PARCUS MEDICAL LLC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON (B)(6) 2023 IT WAS REPORTED TO PARCUS MEDICAL LLC THAT THE ROPE SUTURES KNOTTED IN THE BONE TUNNEL WHICH PREVENTED TENSIONING ON A 41 YEAR OLD FEMALE PATIENT. THERE WAS A 30 MINUTE DELAY IN THE PROCURE. THERE WAS NO NEGATIVE PATIENT IMPACT. THERE WAS NO REPORT OF ANY APPEARANCE ISSUE WITH THE DEVICE OR PACKAGING PRIOR TO USE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION WAS SOLICITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579653 SYND-EZ TITANIUM SUTURE SUSPENSION DEVICE MBI PARCUS MEDICAL LLC 18179

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other