BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GFS ULTIMATE

    MDR report key: 16600587 · Received March 23, 2023

    Report

    Report Number
    3007319107-2023-00010
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    February 9, 2023
    Report Date
    March 31, 2023
    Manufacturer
    PARCUS MEDICAL LLC
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 COMPLETE OF THE INVESTIGATION AT 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 COMPLETE OF THE INVESTIGATION AT THE MANUFACTURING PLANT. SUPPLEMENTAL REPORT: THE REPORTED EVENT CAN NOT BE CONFIRMED AS NO PHOTOS OR VIDEO WAS PROVIDED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURING PLANT FOR ANALYSIS. IT WAS REPORTED TO ANIKA BY THE DISTRIBUTOR THAT DURING A PROCEDURE ON A 29 YEAR OLD WHITE FEMALE PATIENT THE IMPLANT BROKE ON INSERTION AND WAS REMOVED FROM THE SHOULDER AND THEREFORE REMOVED FROM THE BONE. A NEW DEVICE WAS USED. IT IS UNKNOWN IF THE ANCHOR BROKE INTO FRAGMENTS OR IF THERE WERE ANY FRAGMENTS OF THE ANCHOR LEFT IN THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THERE WAS NO REPORT OF ANY UNUSUAL APPEARANCE WITH THE PACKAGING AT THE TIME OF USE. THERE WAS NO DELAY IN THE PROCEDURE. A BATCH RECORD REVIEW WAS PERFORMED. THE ASSEMBLY DID NOT HAVE ANY NON-CONFORMANCES ASSOCIATED WITH IT. THERE WAS A DEVIATION DURING THE MANUFACTURING OF THE PRODUCT. THIS DEVIATION HAD NO IMPACT ON THE MATERIAL INTEGRITY. THE SUBCOMPONENT DID NOT HAVE ANY NON-CONFORMANCE OR DEVIATION ASSOCIATED WITH ITS MANUFACTURING. ALL PRODUCT MANUFACTURED BY ANIKA AND ANIKA ENTITIES 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 NEW AND RELEVANT INFORMATION.

    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. IT WAS REPORTED TO PARCUS MEDICAL LLC ON 09FEB2023 THAT A GFS MINI ULTIMATE ANCHOR BROKE. ON (B)(6) 2023 IT WAS REPORTED THAT THE ANCHOR BROKE UPON INSERTION OF A 29 YEAR OLD FEMALE WHITE PATIENT. IT HAS NOT BEEN CONFIRMED IF THE ANCHOR FRAGMENTED OR IF ALL THE PIECES WERE CONFIRMED REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ANCHOR OF UNREPORTED MAKE/MANUFACTURER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT OR DELAY IN THE PROCEDURE. THE ANCHOR IS NOT AVAILABLE FOR RETURNED. THERE WAS NO REPORT OF ANY UNUSUAL APPEARANCE OF THE DEVICE OR PACKAGE PRIOR TO USE. 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. 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. IT WAS REPORTED TO PARCUS MEDICAL LLC ON 09FEB2023 THAT A GFS MINI ULTIMATE ANCHOR BROKE. ON 01MAR2023, IT WAS REPORTED THAT THE ANCHOR BROKE UPON INSERTION OF A 29 YEAR OLD FEMALE WHITE PATIENT. IT HAS NOT BEEN CONFIRMED IF THE ANCHOR FRAGMENTED OR IF ALL THE PIECES WERE CONFIRMED REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ANCHOR OF UNREPORTED MAKE/MANUFACTURER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT OR DELAY IN THE PROCEDURE. THE ANCHOR IS NOT AVAILABLE FOR RETURNED. THERE WAS NO REPORT OF ANY UNSUAL APPEARANCE OF THE DEVICE OR PACKAGE PRIOR TO USE. ADDITIONAL INFORMATION WAS SOLICITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836490 GFS ULTIMATE FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI PARCUS MEDICAL LLC 17669

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female