BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNOTLESS PUSH-IN SUTURE ANCHOR

    MDR report key: 17106503 · Received June 12, 2023

    Report

    Report Number
    3007319107-2023-00012
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 1, 2023
    Report Date
    July 18, 2023
    Manufacturer
    PARCUS MEDICAL LLC
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 AT THE MANUFACTURING PLANT. SUPPLEMENTAL REPORT. THE REPORTED EVENT COULD NOT BE CONFIRMED. ADDITIONAL INFORMATION WAS NOT PROVIDED UPON REQUEST. THE CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED AND NO DELAY TO THE PROCEDURE REPORTED. IT WAS NOT CONFIRMED THAT ALL THE FRAGMENTS OF THE BROKEN ANCHOR WAS REMOVED FROM THE PATIENT. A REVIEW OF THE BATCH RECORD WAS PERFORMED. THERE WAS NO NONCONFORMANCES RECORDED IN THE MANUFACTURING RECORD. THE PRODUCT WAS MANUFACTURED AND 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.

    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 AT THE MANUFACTURING PLANT.

    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 18MAY2023 THE DISTRIBUTOR REPORTED THAT DURING A DELTOID REPAIR PROCEDURE, THE ANCHOR BROKE WHEN TAPPING INTO THE ANCHOR. THE DOCTOR REPORTED THAT AFTER DRILLING THE DOCTOR WAS TAPPING (NOT HARD) AND THE ANCHOR BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ANCHOR (MANUFACTURER WAS NOT REPORTED). THERE WAS NO REPORTED PATIENT IMPACT OR DELAY IN THE PROCEDURE. 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 THE DISTRIBUTOR REPORTED THAT DURING A DELTOID REPAIR PROCEDURE, THE ANCHOR BROKE WHEN TAPPING INTO THE ANCHOR. THE DOCTOR REPORTED THAT AFTER DRILLING THE DOCTOR WAS TAPPING (NOT HARD) AND THE ANCHOR BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ANCHOR (MANUFACTURER WAS NOT REPORTED). THERE WAS NO REPORTED PATIENT IMPACT OR DELAY IN THE PROCEDURE. ADDITIONAL INFORMATION WAS SOLICITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268851 KNOTLESS PUSH-IN SUTURE ANCHOR SCREW, FIXATION, BONE; FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI PARCUS MEDICAL LLC 17902

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female