BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFFRON ANCHOR

    MDR report key: 17774513 · Received September 19, 2023

    Report

    Report Number
    2125050-2023-01129
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 22, 2023
    Report Date
    January 3, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    PBQ
    PMA / PMN Number
    K220420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXAMINATION REVEALED DEFORMED ANCHOR JUST DISTAL OF THE EYELET WITH CANNULA GOUGE MARKS ASSOCIATED WITH INCORRECT ANCHOR LOADING. AT DEPLOYMENT, MIS-ALIGNED ANCHOR DEFLECTS FROM FIBROUS TISSUE/ BONE CAUSING CONCENTRATED STRESS NEAR CANNULA END RESULTING IN DEFORMED ANCHOR. A REVIEW OF THE DEVICE HISTORY RECORD BY THE CONTRACT MANUFACTURER CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO RELEASED ANCHORS. THE ANCHORS FROM THIS DEVICE RELEASED. THE ANCHORS WERE LOADED AND DEPLOYED TO THE PATIENT. WHEN TESTING THE ANCHORS, THEY EASILY RELEASED FROM THE TISSUE. ANOTHER MANUFACTURER'S DEVICE WAS USED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO RELEASED ANCHORS. THE ANCHORS FROM THIS DEVICE RELEASED. THE ANCHORS WERE LOADED AND DEPLOYED TO THE PATIENT. WHEN TESTING THE ANCHORS, THEY EASILY RELEASED FROM THE TISSUE. ANOTHER MANUFACTURER'S DEVICE WAS USED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518943 SAFFRON ANCHOR SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE PBQ COLOPLAST A/S 8742960_5203501400

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown