BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM LOCKING DRILL GUIDE 4MM-32MM

    MDR report key: 19779252 · Received July 18, 2024

    Report

    Report Number
    3025141-2024-00538
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 18, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE RETURNED 2.0MM LOCKING DRILL GUIDE 4MM-32MM (PART NUMBER 80-0249, BATCH 298559) WAS EXAMINED VISUALLY UNDER MAGNIFICATION. THE FRACTURED SURFACES OF BOTH PIECES FROM THE DRILL GUIDE WERE LIGHTLY TEXTURED AND SHOWED NO SIGNS OF DUCTILITY, WHICH SUGGESTS A BRITTLE FRACTURE MAY HAVE OCCURRED. POSSIBLE CAUSES OF BRITTLE FRACTURES ARE EXCESSIVE STRESS APPLIED ACROSS AN UNANTICIPATED AXIS, INTENSE STRAIN ON THE MATERIAL, AND INCREASED TORQUE DURING INSERTION (FROM CROSS-THREADING OR DAMAGE). 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

    IT WAS REPORTED DURING SURGERY, THE BOLT BROKE OFF AFTER MOUNTING ON THE PLATE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED WITH A REPLACEMENT DEVICE OF THE SAME MODEL AFTER A 10-MINUTE DELAY. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551863 2.0MM LOCKING DRILL GUIDE 4MM-32MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-0249 298559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown