BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIK ANCHOR

    MDR report key: 16468074 · Received March 2, 2023

    Report

    Report Number
    3007319107-2023-00008
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    July 25, 2022
    Report Date
    March 31, 2023
    Manufacturer
    PARCUS MEDICAL LLC
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE REPORTED DEVICE WAS NOT RETURNED TO THE MANUFACTURING PLANT FOR EVALUATION. IT WAS REPORTED TO ANIKA BY THE DISTRIBUTOR THAT THE TIP BROKE OFF OF THE 4.75 SLIK PEEK BEFORE IMPLANTATION ON A 26 YEAR OLD PATIENT FOR A LATERAL ANKLE PROCEDURE. OTHER CONCOMITANT MEDICAL PRODUCT USED WAS 11350 X 1 PARCUS. THE IMPLANT BROKE ON INSERTION AND WAS REMOVED FROM THE TALUS. IT WAS NOT CONFIRMED IF THERE WERE ANY PEICES OF ANCHOR LEFT IN THE PATIENT OR IF ALL THE PIECES OF THE DEVICE WAS REMOVED. A 4MM DRILL W 4.5 TAP WAS USED PRIOR TO THE INSERTION OF THE ANCHOR, BONE DENSITY WAS AVERAGE, THIS WAS A HAGLUNDS REPAIR SO MOST OF THE CORTICAL BONE WAS REMOVED, THE DEVICE WAS STERILE, THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE AND A COMPETITOR'S PRODUCT WAS USED (SWIVELOCK). THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THERE WAS NO REPORT OF ANY UNUSUAL APPEARANCE WITH THE PACKAGING AT THE TIME OF USE. A BATCH RECORD REVIEW WAS PERFORMED AND THERE WERE NO NON-CONFORMANCES OR DEVIATIONS REPORTED WITH ANY OF THE COMPONENTS OR THE ASSEMBLY. ALL PRODUCT MANUFACTURED BY PARCUS MEDICAL LLC ARE RELEASED TO APPLICABLE PROCEDURES AND SPECIFICATIONS. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED AND TRENDED FOR FUTURE ANALYSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION.

    Description of Event or Problem · 0

    ON 08FEB2023, IT WAS REPORTED TO PARCUS MEDICAL LLC THAT THE ANCHOR TIP BROKE DURING TENSIONING ON A 26 YEAR OLD PATIENT WITH UNKNOWN DEMOGRAPHICS. THE ANCHOR WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN IF ANY IMAGES WERE TAKEN TO ENSURE THAT NO ANCHOR FRAGMENTS WERE IN THE PATIENT. THERE WAS NO REPORT OF ANY UNUSUAL DEFECT OR APPEARANCE OF THE ANCHOR PRIOR TO USE. THE TYPE AND SIZE ON THE DRIVER AND OR TAP WAS USED PRIOR TO THE INSERTION OF THE ANCHOR WAS 4MM DRILL W 4.5 TAP TO FOLLOW. BONE DENSITY WAS AVERAGE. THE PROCEDURE WAS A HAGLUNDS REPAIR AND IT WAS REPORTED THAT MOST OF THE CORTICAL BONE WAS REMOVED. IT IS UNKNOWN HOW MANY TIMES THE DRILL AND TAP WERE USED PRIOR TO INSERTION OF THE ANCHOR. A REPLACEMENT SWIVELOCK ANCHOR WAS USED TO COMPLETE THE PROCEDURE WHICH REPORTEDLY CAUSED A DELAY IN THE PROCEDURE BEING COMPLETED. 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 08FEB2023, IT WAS REPORTED TO PARCUS MEDICAL LLC THAT THE ANCHOR TIP BROKE DURING TENSIONING ON A 26 YEAR OLD PATIENT WITH UNKNOWN DEMOGRPHICS. THE ANCHOR WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN IF ANY IMAGES WERE TAKEN TO ENSURE THAT NO ANCHOR FRAGMENTS WERE IN THE PATIENT. THERE WAS NO REPORT OF ANY UNSUAL DEFECT OR APPEARANCE OF THE ANCHOR PRIOR TO USE. THE TYPE AND SIZE ON THE DRIVER AND OR TAP WAS USED PRIOR TO THE INSERTION OF THE ANCHOR WAS 4MM DRILL W 4.5 TAP TO FOLLOW. BONE DENSITY WAS AVERAGE. THE PROCEDURE WAS A HAGLUNDS REPAIR AND IT WAS REPORTED THAT MOST OF THE CORTICAL BONE WAS REMOVED. IT IS UNKNOWN HOW MANY TIMES THE DRILL AND TAP WERE USED PRIOR TO INSERTION OF THE ANCHOR. A REPLACEMENT SWIVELOCK ANCHOR WAS USED TO COMPLETE THE PROCEDURE WHICH REPORTEDLY CAUSED A DELAY IN THE PROCEDURE BEING COMPLETED. ADDITIONAL INFORMATION WAS SOLICITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454248 SLIK ANCHOR SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER MBI PARCUS MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Unknown