BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAP SPACER

    MDR report key: 20306704 · Received September 25, 2024

    Report

    Report Number
    1020279-2024-01931
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 25, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWT
    UDI-DI
    00885556578445
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 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 TKA SURGERY, A GAP SPACER BROKE WHILE TESTING GAP BALANCE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244243 GAP SPACER TEMPLATE HWT SMITH & NEPHEW, INC. UNKNOWN 00885556578445

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown