BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL BONE SCREW, Ø3.5MM X 24MM

    MDR report key: 21503673 · Received March 3, 2025

    Report

    Report Number
    1220246-2025-00756
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    October 29, 2024
    Report Date
    June 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    UDI-DI
    00848665033199
    PMA / PMN Number
    K080590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION THAT AN ALPHA PLATE BROKE POSTOPERATIVELY IS CONFIRMED. HOWEVER, THERE IS NO PROBLEM FOUND WITH THE RECEIVED SCREW. ONE UNPACKAGED 8110-024, CORTICAL BONE SCREW, BATCH NUMBER 213014, WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION NOTED THAT THE SCREW'S HEAD WAS STRIPPED, LIKELY DUE TO THE IMPLANTATION AND EXPLANATION PROCESS (REVISION SURGERY, (B)(6) 2024). FUNCTIONAL TESTING NOTED THAT THE SCREW EXHIBITED RESISTANCE DURING BOTH INSERTION AND REMOVAL. THIS RESISTANCE WAS ATTRIBUTED TO VISIBLE DAMAGE ON THE THREADS OF BOTH THE SCREW AND THE CORRESPONDING PLATE. DIMENSIONAL VERIFICATION WAS CONDUCTED USING CALIPER ID: 1018793, WHICH CONFIRMED THE SCREW DIMENSIONS AS Ø3.5 MM X 24 MM. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT. PER DFU-0139-EO, REVISION 1: "POSTOPERATIVELY AND UNTIL HEALING IS COMPLETE, FIXATION PROVIDED BY THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT-BEARING OR OTHER UNSUPPORTED STRESS. THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POSTOPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE DEVICE."

    Description of Event or Problem · 0

    ON 12/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ALPHA PLATE BROKE POSTOPERATIVELY. THE PATIENT WAS PICKING UP THE CAT AND FELT A BREAK. X-RAYS CONFIRM THE PLATE BROKE THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 2/6/2025: ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE LEFT ALPHA PLATE BREAKING AND CAUSING THE REINFORCED STRAIGHT PLATE TO DISLODGE. A 3024-011 LEFT ALPHA PLATE, AN AR-8935-24 LOW PROFILE SCREW, TITANIUM, NON-LOCKING, AN 8110-026 CORTICAL BONE SCREW, AN 8110-024 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREW, TWO 8124-036 CANCELLOUS LOCKING SCREW, TWO 8124-044 CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, AN 8124-048 CANCELLOUS LOCKING SCREW, AN 8124-046 CANCELLOUS LOCKING SCREW, THREE 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-042 CANCELLOUS LOCKING SCREW, AN 8124-038 CANCELLOUS LOCKING SCREW, AND AN 8124-030 CANCELLOUS LOCKING SCREW, AN AR-18827P-16 20 HOLE REINFORCED STRAIGHT PLATE, AN AR-18827-30 CORTICAL SCREW, AR-18827-18 CORTICAL SCREW, AR-18827V-18, AN AR-18827V-16 VAL SCREW, AN AR-18827V-22 VAL SCREW, TWO AR-18827V-20 VAL SCREW AN AR-18827V-10 VAL SCREW, AND AN ABS-2010-10 ALLOSYNC PURE WERE EXPLANTED DURING THE REVISION SURGERY. DURING THE REMOVAL OF THE SCREWS, TWO BROKE OFF. AT THIS TIME, IT IS UNKNOWN WHAT WERE THE PART NUMBERS OF THE BROKEN SCREWS AND IF THEY WERE FULLY REMOVED FROM THE PATIENT. THE REVISION SURGERY WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345088 CORTICAL BONE SCREW, Ø3.5MM X 24MM FIXATN NAIL/BLADE/PLATE COMBO KTW ARTHREX, INC. CORTICAL BONE SCREW, Ø3.5MM X 24MM 213014 00848665033199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other