BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 21734299 · Received March 31, 2025

    Report

    Report Number
    3025141-2025-00124
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    March 5, 2025
    Report Date
    March 31, 2025
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED SCREW WAS NOT RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE MODEL NUMBER AND BATCH/LOT NUMBER OF THE SCREW IS UNKNOWN. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND FOR THE RETURNED 1.5MM HEX DRIVER TIP, LOCKING GROOVE (80-0728) AND THE MINI-AO TORQUE LIMITING DRIVER (80-1008) WERE EXAMINED VISUALLY UNDER MAGNIFICATION. THE FRACTURE SURFACE OF THE DRIVER SPIRALS ALONG THE LENGTH OF THE TIP, ANGLING UPWARD TO A SHARP POINT, INDICATING POTENTIAL TORSIONAL LOADING TO FAILURE. THE FRACTURE SURFACE IS DULL AND GRAINY IN APPEARANCE, INDICATING A BRITTLE FRACTURE FROM A SINGLE OVERLOAD EVENT. THE DRIVER HANDLE SHOWED NO SIGNIFICANT OUTWARD SINGS OF WEAR OR DAMAGE. THE HANDLE CONNECTOR WAS UNSCREWED SLIGHTLY FROM THE MAIN BODY WITH A VISABLE GAP BETWEEN THE ORANGE HANDLE AND THE DRIVER CONNECTOR PORTION OF THE HANDLE. FUNCTIONAL TESTING CONFIRMED THAT THE DRIVER HANDLE WAS ABLE TO SUCCESSFULLY LOCK IN A DRIVER. HEX TIP BREAKAGE MAY OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE DRIVER DURING USE TO OVERCOME INCREASED RESISTANCE. BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED. RELATED SUBMISSION NAME: 3025141-2025-00122 AND 3025141-2025-00123.

    Description of Event or Problem · 0

    WHILE IMPLANTING 2.3MM SCREWS IN THE DISTAL ROW, THE 1.5 MM HEX DRIVER TIP BROKE. THE ORANGE HANDLE ALSO MESSED UP. A DIFFERENT DRIVER TIP AND HANDLE WAS USED TO COMPLETE THE CASE. A DELAY OF 15 MINUTES WAS REPORTED AND THE PATIENT WAS STABLE WITH NO OTHER REPORTED EFFECTS. REPORT IS 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913522 SCREW, FIXATION, BONE HWC ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female