BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM QFX SCREW 12MM

    MDR report key: 22710831 · Received August 5, 2025

    Report

    Report Number
    1020279-2025-01348
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 16, 2025
    Report Date
    August 5, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    UDI-DI
    03596010623409
    PMA / PMN Number
    K210837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: CASE-(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 AN INTERNAL FIXATION SURGERY, USING A 2.0MM QFX SCREW 12MM TO FIXATE A DISTAL METATARSAL OSTEOTOMY, UPON INSERTION A SIDE TO SIDE ROCKING MOTION WAS APPLIED TO ATTEMPT TO GET THE SCREW TO SNAP OFF THE DRIVER INSERTER PORTION BUT RATHER THAN 'SNAPPING OFF' AS THEY ARE SUPPOSED TO, IT REMAINED ATTACHED TO THE PIN DRIVER. THIS FORCE CAUSED THE SCREW TO BREAK THROUGH THE DORSAL CORTEX OF THE BONE WHICH LED TO LOSS OF FIXATION. THE FRACTURED SCREW WAS REMOVED. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2635063 2.0MM QFX SCREW 12MM PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. UNKNOWN 03596010623409

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male