BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL TAPERED 3.8MM

    MDR report key: 22145539 · Received June 4, 2025

    Report

    Report Number
    1219602-2025-01351
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 13, 2025
    Report Date
    June 4, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010610607
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: 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 INVESTIGATIVE FINDINGS OR 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 A SHOULDER CUFF RECONSTRUCTION PROCEDURE, WHEN THE ANCHOR WAS BEING INITIALLY PLACED, THE AWL TAPERED IMPACTOR BROKE, DAMAGING IT. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852352 AWL TAPERED 3.8MM ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 50507072 03596010610607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female