BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED CANNULATED AWL

    MDR report key: 21351224 · Received February 10, 2025

    Report

    Report Number
    1020279-2025-00262
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 26, 2025
    Report Date
    February 10, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSB
    UDI-DI
    00885556266649
    PMA / PMN Number
    K122170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING AN ORIF SURGERY, THE ORANGE HANDLE OF ONE (1) CURVED CANNULATED AWL BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND IF THERE WAS ANY DELAY. NO INJURIES WERE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836333 CURVED CANNULATED AWL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SMITH & NEPHEW, INC. UNKNOWN 00885556266649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown