BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF BALL JNT SCREWDRIVER SHAFT

    MDR report key: 23700186 · Received December 2, 2025

    Report

    Report Number
    1020279-2025-01991
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 14, 2025
    Report Date
    December 15, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HXX
    UDI-DI
    03596010454201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 RISKS WITH THE DEVICE ITSELF OR WITH ITS USE 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 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 THR SURGERY ONE (1) REF BALL JNT SCREWDRIVER SHAFT BROKE WHEN THE SURGEON WAS REMOVING IT FROM THE LAST SCREW THAT NEEDED TO BE PUT IN. THE SCREWDRIVER WAS USED IN SURGERY TO PLACE TWO SCREWS AND WAS DISCOVERED TO BE BROKEN AFTER IT WAS FINISHED BEING USED WHILE SITTING ON THE BACK TABLE. NOTHING WAS LEFT ON THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A THR SURGERY ONE (1) REF BALL JNT SCREWDRIVER SHAFT BROKE WHEN THE SURGEON WAS REMOVING IT FROM THE LAST SCREW THAT NEEDED TO BE PUT IN. NOTHING WAS LEFT ON THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900177 REF BALL JNT SCREWDRIVER SHAFT SCREWDRIVER HXX SMITH & NEPHEW, INC. 15KSY0034 03596010454201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown