BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL BONE SCREW, Ø3.5MM X 30MM

    MDR report key: 20914625 · Received December 12, 2024

    Report

    Report Number
    1220246-2024-08801
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    October 29, 2024
    Report Date
    February 27, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    UDI-DI
    00848665033229
    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

    ONE UNPACKAGED 8110-030 CORTICAL BONE SCREW, Ø3.5MM X 30MM SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED DAMAGE TO THE SCREW THREADS NEAR THE HEAD. EVALUATION OF THE SCREW¿S HEX HEAD SHOWED SCRATCHES. THE OBSERVED DAMAGE ON THE SCREW IS MOST LIKELY DUE TO IT BEING IMPLANTED AND THEN REMOVED. FUNCTIONAL TESTING WAS CONDUCTED BY SCREWING THE RETURNED SCREWS INTO THE RETURNED 3024-011 ALPHA PLATE, LEFT, 11-HOLE, SERIAL/BATCH NUMBER (B)(6). IT WAS NOTED THAT THE SCREWS DID NOT ATTACH TO THE PLATE BY THEMSELVES; HOWEVER, THIS IS EXPECTED AS THESE SCREWS ARE DESIGNED TO BE SCREWED DIRECTLY INTO THE BONE TO HOLD THE PLATE IN PLACE. ARTHREX CONCLUDED THAT THERE ARE NO ALLEGATIONS AGAINST THE 8110-030 BATCH 230453. NO RELATED PROBLEM FOUND.

    Description of Event or Problem · 0

    ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3024-01 11-HOLE LEFT ALPHA PLATE BROKE POSTOPERATIVELY THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH THE PLATE, AND REVISION SURGERY IS STILL TO BE DETERMINED. PER THE SALES REPRESENTATIVE, THE PATIENT DID NOT REPORT ANY FALLS OR INJURIES. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 11/13/2024: DURING THE INITIAL SURGERY ON (B)(6) 2024, A 3024-011 11-HOLE LEFT ALPHA PLATE, TWO 8110-026 CORTICAL BONE SCREW, AN 8110-028 CORTICAL BONE SCREW, THREE 8110-030 CORTICAL BONE SCREWS, AN 8114-024 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-028 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-030 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-028 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, FULLY THREADED, AN 8124-038 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-046 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-048 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-050 FULLY THREADED CANCELLOUS LOCKING SCREW, AN AR-8935CL-18 KREULOCK COMPRESSION SCREW, AND AN ABS-2010-10 ALLOSYNC PURE WERE IMPLANT. AN ABS-10062T ANGEL CPRP SYSTEM WITH ASPIRATION KIT WAS ALSO USED DURING THE PROCEDURE. ON (B)(6) 2024, IT WAS DISCOVERED THAT THE PLATE HAD BROKEN. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024. ALL THE HARDWARE FROM THE ORIGINAL SURGERY ON (B)(6) 2024 WAS REMOVED AND REPLACED WITH PRODUCTS FROM ANOTHER MANUFACTURER, A 10CC OF ARTHREX ALLOSYNC PURE DBM, 5CC OF ARTHREX ARTHROCELL PLUS, AND BONE MARROW ASPIRATE FROM THE ILIAC CREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168685 CORTICAL BONE SCREW, Ø3.5MM X 30MM FIXATN NAIL/BLADE/PLATE COMBO KTW ARTHREX, INC. CORTICAL BONE SCREW, Ø3.5MM X 30MM 230453 00848665033229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other