BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 16477121 · Received March 3, 2023

    Report

    Report Number
    1220246-2023-06373
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    February 10, 2023
    Report Date
    September 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO APPLYING EXCESSIVE MECHANICAL FORCES DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN UNKNOWN PUNCH IMPACTOR SECTION BROKE OFF WHILE BEING MALLETED INTO THE PATIENT. THE SURGEON USED THE PUNCH UNTIL IT WAS DOWN AND REMOVED IT FROM THE PATIENT. ADDITIONALLY, AN AR-18700-40 FORCEPS BENT DURING THE CASE. CASE INVOLVEMENT, PUNCH BROKE DURING USE, AND FORCEPS WERE DAMAGED WITH NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058784 UNK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown