BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII DSH ART TRL 1-2 11MM

    MDR report key: 23075534 · Received September 17, 2025

    Report

    Report Number
    1020279-2025-01555
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 15, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010481351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). H11 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE PHOTOGRAPHS WERE REVIEWED, AND REVEALED THAT THE DEVICE IS FRACTURED. DEVICE BATCH NUMBER WAS NOT PROVIDED, THUS, AN EVALUATION OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. A REVIEW OF COMPLAINT HISTORY FOR THE PREVIOUS 12 MONTHS DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY POTENTIAL FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A TKA SURGERY, A PLASTIC PIECE OF ONE (1) GII DSH ART TRL 1-2 11MM CHIPPED OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731350 GII DSH ART TRL 1-2 11MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. UNKNOWN 03596010481351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown