BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST PEEK SUTURE ANCHOR

    MDR report key: 18650648 · Received February 6, 2024

    Report

    Report Number
    3007319107-2024-00004
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 1, 2024
    Report Date
    March 5, 2024
    Manufacturer
    PARCUS MEDICAL LLC
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS STILL UNDER INVESTIGATION AT THE MANUFACTURING PLANT. THE BRAND NAME, COMMON DEVICE NAME AND PRODUCT CODES ARE ASSUMED AND MAY BE REVISED UPON RECEIPT OF NEW AND RELEVANT INFORMATION. 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 IS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURING PLANT FOR ANALYSIS. IT WAS REPORTED TO ANIKA BY THE DISTRIBUTOR THAT A SURGEON HAD TO DRILL OUT AN OLD ANCHOR TO PUT IN A NEW ANCHOR FOR A REVISION CASE AS THE 47-YEAR-OLD FEMALE PATIENT WHO HAD BEEN NON-COMPLIANT HAD NOT FOLLOWED AFTER CARE INSTRUCTIONS THAT RESULTED IN TEARING IN THE SURGERY SITE. THE PATIENT WALKED AND TEARED THE TISSUE AROUND THE SURGERY. BASED ON THE INFORMATION PROVIDED, THERE WERE NO REPORTED ISSUES OR ABNORMALITIES WITH THE PACKAGING OR DEVICE DURING ITS USE. THERE WAS NO PATIENT DEATH. THERE WAS NO REPORT OF AN UNPLANNED OR UNSCHEDULED MEDICAL INTERVENTION. THERE WAS NO DELAY IN THE PROCEDURE. THE STATUS OF THE PATIENT IS UNKNOWN. A REVIEW OF THE BATCH RECORD WAS PERFORMED. THERE WAS NO NONCONFORMANCES DOCUMENTED IN THE BATCH RECORD. A THREE-YEAR RETROSPECTIVE REVIEW OF ALL NONCONFORMANCES WAS PERFORMED. THERE WAS NO NONCONFORMANCES DOCUMENTED THAT WAS ASSOCIATED WITH THE REPORTED EVENT. THE PLAUSIBLE CAUSE OF THE REPORTED EVENT IS TRACED TO THE PATIENT BEING NONCOMPLIANT AND FAILED TO FOLLOW AFTER CARE INSTRUCTIONS RESULTING IN THE TISSUE NOT HEALING CORRECTLY RESULTING IN A REVISION PROCEDURE BEING PERFORMED. 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 AT THE MANUFACTURING PLANT. THE BRAND NAME, COMMON DEVICE NAME AND PRODUCT CODES ARE ASSUMED AND MAY BE REVISED UPON RECEIPT OF NEW AND RELEVANT INFORMATION. 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 (B)(6)2023 THE DISTRIBUTOR REPORTED TO PARCUS MEDICAL LLC THAT A REVISION PROCEDURE WAS PERFORMED FOR A WOUND DEHISCENCE ON A 47-YEAR-OLD FEMALE PATIENT WHO WAS NONCOMPLIANT AFTER RECEIVING AN UNKNOWN PARCUS ANCHOR. THE ORIGINAL DATE THE PATIENT RECEIVED THE PARCUS ANCHOR IS UNKNOWN. THERE WAS NO DIRECT ALLEGATION THAT THE PARCUS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S NONCOMPLIANCE OR THE WOUND DEHISCENCE. THE PATIENT WAS LISTED AS BEING NONCOMPLIANT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION PRIOR TO OR DURING THE USE OF THE PARCUS ANCHOR. THIS IS ONE OF THREE SUBMISSIONS FOR THE SAME EVENT.

    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 05JAN2023 THE DISTRIBUTOR REPORTED TO PARCUS MEDICAL LLC THAT A REVISION PROCEDURE WAS PERFORMED FOR A WOUND DEHISCENCE ON A 47-YEAR-OLD FEMALE PATIENT WHO WAS NONCOMPLIANT AFTER RECEIVING AN UNKNOWN PARCUS ANCHOR. THE ORIGINAL DATE THE PATIENT RECEIVED THE PARCUS ANCHOR IS UNKNOWN. THERE WAS NO DIRECT ALLEGATION THAT THE PARCUS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S NONCOMPLIANCE OR THE WOUND DEHISCENCE. THE PATIENT WAS LISTED AS BEING NONCOMPLIANT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION PRIOR TO OR DURING THE USE OF THE PARCUS ANCHOR. THIS IS ONE OF THREE SUBMISSIONS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087345 TWIST PEEK SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI PARCUS MEDICAL LLC 17611

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female