BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2 - NAIL HOLDING SCREW, TIBIA 10 MM

    MDR report key: 22064177 · Received May 21, 2025

    Report

    Report Number
    0008031020-2025-00907
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 11, 2025
    Report Date
    July 31, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    UDI-DI
    04546540196484
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION IS COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE DEVICE WAS RETURNED AND COULD NOT BE ASSEMBLED PROPERLY. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE NAIL HOLDING SCREW (LOT K953367) IS HIGHLY WORN OUT AND PARTIALLY DEFORMED AT THE SHAFT SECTION CLOSE TO THE THREADS. THIS IS MOST LIKELY DUE TO REPETITIVE FRICTION, THEREFORE CAUSING LOCAL ACCUMULATION OF MATERIAL AND THICKENING. THE INNER PART OF THE NAIL HANDLE IS HIGHLY WORN OUT, WHICH LED TO LOCAL DEFORMATION FROM REPETITIVE FRICTION. BOTH NAIL HOLDING SCREWS (WORN OUT ONE AND INTACT ONE) COULD NOT BE INSERTED THROUGH THE NAIL HANDLE AS INTENDED. THEY BOTH JAMMED AT THE LEVEL OF THE OBSERVED INNER DEFORMATION. A FULLY FUNCTIONAL NAIL HANDLE SAMPLE WAS THEN USED. THE DEFORMED NAIL HOLDING SCREW COULD NOT BE INSERTED AS PREVIOUSLY. THE DAMAGES OBSERVED ON THE NAIL HOLDING SCREW (LOT K953367) AND THE INNER NAIL HANDLE WERE MOST LIKELY MUTUALLY CAUSED DUE TO FRICTION AND FORCED ASSEMBLY OVERTIME. THE DIMENSIONAL INSPECTION CONFIRMED THE ABOVE. THERE IS A LOCAL DEFORMATION INSIDE THE NAIL HANDLE, REDUCING THE INNER DIAMETER. THEREFORE, BOTH NAIL HOLDING SCREWS CANNOT BE INSERTED ANYMORE. IN ADDITION, THE DEFORMATION OF THE NAIL HOLDING SCREW (LOT K953367) CAUSED ITS DIAMETER TO BE LARGER, AND THEREFORE PREVENTING IT FROM BEING INSERTED EVEN INTO A FUNCTIONAL NAIL HANDLE. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE DEVICES WERE MOST LIKELY NOT INSPECTED AND TESTED PROPERLY BEFORE THE PROCEDURE, LEADING TO UNNOTICED DEFORMATION DUE TO WEAR ON THE NAIL HOLDING SCREW AND NAIL HANDLE. IT IS WORTH NOTING THE DEVICE WAS MANUFACTURED IN 2011, APPROXIMATELY 14 YEARS AGO. THEREFORE, NORMAL WEAR MOST CERTAINLY ALSO PLAYED A ROLE IN THE REPORTED EVENT. AS A REMINDER, THE STRYKER INSTRUCTIONS FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE HELP TO DETERMINE WHETHER AN INSTRUMENT IS IN GOOD CONDITION OR MUST BE REPLACED DUE TO EXCESSIVE WEAR OR OBVIOUS DEFECTS. THE INSTRUCTIONS FOR USE ALSO STATE: BEFORE EVERY OPERATION, ENSURE THAT ALL DEVICES TO BE USED DURING THE OPERATION FUNCTION CORRECTLY WITH EACH OTHER. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    AS REPORTED: "THE INSTRUMENTS, ONCE THE PATIENT HAD ALREADY BEEN ANESTHETIZED, WERE FOUND TO BE DEFECTIVE AND UNUSABLE. OUR AGENT HAD TO URGENTLY DELIVER ANOTHER INSTRUMENT, WHICH WAS WITHDRAWN IN AN EMERGENCY FROM ONE OF OUR DEPOSIT ACCOUNTS, CAUSING CONSIDERABLE INCONVENIENCE TO BOTH CUSTOMERS AND SIGNIFICANTLY LENGTHENING THE DURATION OF THE OPERATION."

    Description of Event or Problem · 0

    AS REPORTED: "THE INSTRUMENTS, ONCE THE PATIENT HAD ALREADY BEEN ANESTHETIZED, WERE FOUND TO BE DEFECTIVE AND UNUSABLE. OUR AGENT HAD TO URGENTLY DELIVER ANOTHER INSTRUMENT, WHICH WAS WITHDRAWN IN AN EMERGENCY FROM ONE OF OUR DEPOSIT ACCOUNTS, CAUSING CONSIDERABLE INCONVENIENCE TO BOTH CUSTOMERS AND SIGNIFICANTLY LENGTHENING THE DURATION OF THE OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45051 T2 - NAIL HOLDING SCREW, TIBIA 10 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH K953367 04546540196484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown