BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE ADAPTIVE

    MDR report key: 21098319 · Received January 7, 2025

    Report

    Report Number
    3007593722-2024-00019
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 11, 2024
    Report Date
    August 1, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    GAT
    UDI-DI
    M97015000007200
    PMA / PMN Number
    D201781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS OPENED FOR A REPORT OF A TIP OF AN ECLIPSE IMPLANT INSERTER THAT BROKE OFF DURING SURGERY. THE REPORT STATES THAT THE THREADED TIP OF AN INSERTER BROKE OFF WHEN THE ANCHOR (7MM X 2MM) WAS DEPLOYED FROM THE ECLIPSE DISPOSABLE GUN AND REMAINS IN THE PATIENT. AN IMAGE WAS PROVIDED OF THE BROKEN INSERTER BY THE SALES REPRESENTATIVE. THE PRODUCT WAS NOT RETURNED, AND NO FURTHER INFORMATION WAS PROVIDED SO A COMPLETE EVALUATION AND INVESTIGATION COULD NOT BE CONDUCTED. IN THE ECLIPSE DESIGN RISK MATRIX DOCUMENT, RISK-FA006-001 (MEDSHAPE ED-50142-06) REV A. THE POTENTIAL FAILURE OF THE DELIVERY SYSTEM (DEPLOYMENT GUN) BREAKING IN IMPLANT ON INSERTION IS RECORDED AND ACCOUNTED FOR. THE POTENTIAL CAUSE FOR THIS FAILURE IS IF THE SURGEON INSERTS THE INSERT OFF ANGLE, SPECIFICALLY, AN ANGLE NOT IN LINE WITH RESPECT TO THE BONE TUNNEL AXIS. THIS POTENTIAL FAILURE IS RANKED WITH A DETECTION OF 1, A SEVERITY OF 2 (DEVICE SEVERITY OF 3) AND AN OCCURRENCE OF 1. A HISTORICAL SEARCH FROM 03/01/2024 TO 12/11/2024 WAS CONDUCTED AND RESULTS SHOWED THAT THIS WAS THE FIRST OCCURRENCE OF THIS FAILURE MODE FOR THIS PRODUCT FAMILY. THIS IS AN ISOLATED CASE, AND THE FIRST OCCURRENCE REPORTED. THE HAZARD IS AN ANTICIPATED RISK WITHIN THE RISK ANALYSIS MATRIX AND A SINGLE OCCURRENCE IS NOT AN INDICATION OF A SYSTEMATIC ISSUE NECESSITATING A CAPA INVESTIGATION. THEREFORE, NO FURTHER ACTION IS NEEDED. THIS IS AN ISOLATED CASE, AND THE FIRST OCCURRENCE REPORTED. THE HAZARD IS AN ANTICIPATED RISK WITHIN THE RISK ANALYSIS MATRIX AND A SINGLE OCCURRENCE IS NOT AN INDICATION OF A SYSTEMATIC ISSUE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE

    Description of Event or Problem · 0

    INSTRUMENT BREAKAGE - FRAGMENTED PIECES LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870396 ACTIVE ADAPTIVE ECLIPSE, 7MM X 20MM GAT MEDSHAPE, INC. 04782 M97015000007200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other