BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAW TIGHT SUTURE ANCHORS

    MDR report key: 16362224 · Received February 13, 2023

    Report

    Report Number
    3007319107-2023-00005
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 23, 2023
    Report Date
    March 17, 2023
    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. SUPPLEMENTAL INFORMATION. THE REPORTED EVENT CANNOT BE CONFIRMED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IT WAS REPORTED TO PARCUS BY THE DISTRIBUTOR THAT AN ANCHOR PULLED OUT OF THE BONE DURING A LAR PROCEDURE FOR A 36 YEAR OLD MALE PATIENT. THE ANCHOR WAS NOT IMPLANTED, IT WAS DISCARDED, A LARGER ANCHOR WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS THOUGHT THAT THE ANCHORS PULLED OUT DUE TO POOR BONE QUALITY AND PROPER SURGICAL TECHNIQUE WAS USED. ADDITIONAL INFORMATION WAS NOT PROVIDED UPON REQUEST. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION. THIS CASE WILL BE MONITORED AND TRENDED FOR FUTURE ANALYSIS.

    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.

    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 25JAN2023, IT WAS REPORTED TO PARCUS LLC THAT THE DRAW TIGHT ANCHOR PULLED OUT OF A 36 YEAR OLD MALE PATIENT'S BONE DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD POOR BONE QUALITY. THE COMPLAINANT DID NOT BELEIVE THAT THERE WAS ANY PROBLEM WITH THE ANCHOR. THE ANCHOR WAS DISCARDED. THIS IS ONE OF THREE EVENTS INVOLVING THE SAME PATIENT. A LARGER SIZE ANCHOR WAS USED AS A REPLACEMENT. IT WAS NOT DISCLOSED THE BRAND OR MANUFACTURER OF THE REPLACEMENT ANCHOR. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. THERE WAS NO DELAY OF THE PROCEDURE REPORTED. ADDITIONAL INFORMATION WAS SOLICITED.

    Description of Event or Problem · 0

    ON 25JAN2023 IT WAS REPORTED TO PARCUS LLC THAT THE DRAW TIGHT ANCHOR PULLED OUT OF A 36 YEAR OLD MALE PATIENT'S BONE DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD POOR BONE QUALITY. THE COMPLAINANT DID NOT BELIEVE THAT THERE WAS ANY PROBLEM WITH THE ANCHOR. THE ANCHOR WAS DISCARDED. THIS IS ONE OF THREE EVENTS INVOLVING THE SAME PATIENT. A LARGER SIZE ANCHOR WAS USED AS A REPLACEMENT. IT WAS NOT DISCLOSED THE BRAND OR MANUFACTURER OF THE REPLACEMENT ANCHOR. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. THERE WAS NO DELAY OF THE PROCEDURE REPORTED. ADDITIONAL INFORMATION WAS SOLICITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703896 DRAW TIGHT SUTURE ANCHORS FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI PARCUS MEDICAL LLC 17368

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male