BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ARTELON ANCHOR

    MDR report key: 20938860 · Received December 16, 2024

    Report

    Report Number
    3010673515-2024-00002
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    April 19, 2022
    Report Date
    December 16, 2024
    Manufacturer
    ARTELON
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS PART OF A REMEDIATION PERFORMED BY STRYKER FOLLOWING THE ACQUISITION OF ARTELON COMPANY. THIS CASE HAS ALREADY CONCLUDED WITH MINIMAL INFORMATION. THEREFORE, NO SUPPLEMENTAL MDR WILL BE SUBMITTED UNLESS ADDITIONAL INFORMATION IS PROVIDED THIS INVESTIGATION IS PART OF THE ARTELON REMEDIATION AIMING TO TRANSFER THE DATA HISTORY INTO TW. AN INVESTIGATION OF THIS CASE HAS ALREADY BEEN PERFORMED BY ARTELON - PLEASE REFER TO ATTACHMENT. THE CONCLUSION OF THE INVESTIGATION STATES "FEEDBACK RECEIVED ON 4.5MM DRILL BIT. USER DID NOT HAVE 5.0MM ANCHORS, AS RECOMMENDED WHEN USING 4.5MM DRILL BIT. CAPA NOT REQUIRED. ISOLATED INCIDENT, CONTINUE TO MONITOR FOR REOCCURRENCE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT RECEIVED A 1/5 RATING FOR OVERALL FIXATION. FEEDBACK FROM THE JOT FORM INDICATED THAT THE ANCHOR DID NOT HOLD IN PLACE WHEN THE DRILL WAS APPLIED TO THE CALCANEUS, LIKELY DUE TO SOFTER BONE AT THE INSERTION SITE. IT WAS NOTED THAT THE SITE DID NOT HAVE ANY 5.0 ANCHORS AVAILABLE. SUGGESTIONS WERE MADE TO CONSIDER THIS ISSUE IN FUTURE PLANNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312929 UNKNOWN ARTELON ANCHOR MESH, SURGICAL, POLYMERIC FTL ARTELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown