BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 19537426 · Received June 14, 2024

    Report

    Report Number
    3025141-2024-00503
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 1, 2024
    Report Date
    June 12, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED SCREW WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE MODEL NUMBER AND BATCH/LOT NUMBER OF THE SCREW IS UNKNOWN. HOWEVER, THE REPORTED DRIVERS WERE RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE TWO RETURNED 1.5MM CANN. QUICK RELEASE DRIVER TIP (PART NUMBER HT-0915, BATCH NUMBERS 499767 AND 251210) WERE EXAMINED VISUALLY UNDER MAGNIFICATION. BOTH DRIVERS SHOWED SIGNS OF USE WITH DAMAGE TO THE TIP. TORSIONAL AND OBLIQUE FRACTURE PATTERNS WERE IDENTIFIED AT THE TRANSITION FROM THE RADIUS TO THE HEX TIPS. BATCH NUMBER 251210 HAD MORE OF A FLUSH TORSIONAL FRACTURE. A TORSIONAL FRACTURE PATTERN LIKELY INDICATES AN EXCESSIVE TWISTING LOAD ABOUT THE DRIVER'S CENTRAL AXIS, WHILE AN OBLIQUE FRACTURE PATTERN LIKELY INDICATES SOME SIDE LOADING (BENDING), AWAY FROM THE DRIVER'S CENTRAL AXIS, WAS ALSO APPLIED TO THE HEX TIP. HEX TIP BREAKAGE MAY OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE DRIVER DURING USE TO OVERCOME INCREASED RESISTANCE. THIS INCREASED RESISTANCE CAN HAVE MANY CONTRIBUTING FACTORS SUCH AS ENCOUNTERING DENSE BONE OR INADEQUATE PILOT HOLE DEPTH. HOWEVER, BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    (REPORT 3 OF 3) IT WAS REPORTED DURING SURGERY WHEN THE SURGEON TRIED TO INSERT A MICRO ACUTRAK 2 SCREW TO THE BONE, TWO DRIVER TIPS BROKE. IT WAS ALSO REPORTED THAT ONE DRIVER TIP BROKE OFF AT AN ANGLE AND THE OTHER DRIVER TIP BROKE OFF HORIZONTALLY AND TWISTED. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT'S BODY. THE SURGERY WAS COMPLETED WITH NO DELAY. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THERE ARE 3 RELATED REPORT NUMBERS FOR THIS EVENT 3025141-2024-00501 - 3025141-2024-00503.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183946 SCREW, FIXATION, BONE HWC ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown