BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX FILPCUTTER FROM THE QUADLINK IMPLANT SYSTEM

    MDR report key: 21243612 · Received January 27, 2025

    Report

    Report Number
    MW5165296
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 21, 2025
    Manufacturer
    ATHREX INC.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ARTHREX FILPCUTTER FROM THE QUADLINK IMPLANT SYSTEM REF AR_1288QIS-100 LOT#15280763 EXP 2028-05-31. DURING THE DRILLING OF THE ACL REVISION TUNNEL, THE TIP OF THE FLIPCUTTER BROKE OFF AND HAD TO BE FISH OUT AND RECOVERED ALL OF THE MISSING TIP. ARTHREX REP (B)(4) IS AWARE OF THE EVENT AND SAID WILL ALSO REPORT IT. TYPE OF EVENT: DEVICE FAILURE LOT NO: 15280763.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501130 ARTHREX FILPCUTTER FROM THE QUADLINK IMPLANT SYSTEM FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ATHREX INC. 15280763

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male