BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE, 2.0MM

    MDR report key: 13087984 · Received December 27, 2021

    Report

    Report Number
    1220246-2021-04214
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    December 6, 2021
    Report Date
    December 27, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867312746
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE INNER COLLET BROKE IN TWO. THE ID OF THE BROKEN FRAGMENT MET SPECIFICATIONS. THE PRONGS OF THE BROKEN FRAGMENT ARE ALSO BENT, DENTED AND DISCOLORED. THE CAUSE OF THE EVENT IS UNDETERMINED.

    Description of Event or Problem · 0

    ON 12/07/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT A AR-18700-49 CLAMP, AND A R-18700-25 SLEEVE ARE BROKEN. THIS OCCURRED ON (B)(6) 2021 DURING A PROCEDURE. THERE WAS NO PATIENT EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988834 HOLDING SLEEVE, 2.0MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. HOLDING SLEEVE, 2.0MM 1391947 00888867312746

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown