BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM LOCKING DRILL GUIDE 4MM-32MM

    MDR report key: 21173279 · Received January 16, 2025

    Report

    Report Number
    3025141-2025-00030
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 25, 2024
    Report Date
    February 10, 2025
    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 NUMBER 282478) WAS EXAMINED VISUALLY UNDER MAGNIFICATION. THERE WAS WEAR OR DAMAGE ON THE DRILL GUIDE ON THE FIRST THREAD FROM THE TIP OF THE GUIDE. THE OVERALL BODY EXHIBITED A LIGHT BROWN SHEEN FROM OXIDATION OF THE PART FROM MULTIPLE REPROCESSING. THE FRACTURE PATTERN APPEARED TO INDICATE A BRITTLE FRACTURE EVENT FROM A SINGULAR LOAD EVENT RATHER THAN CONTINUAL WEAR. PHYSICAL EXAMINATION OF FUNCTIONALITY WAS DEEMED UNNECESSARY AS THE THREADED END OF THE GUIDE WAS BROKEN AND FUNCTIONALITY WAS CERTAIN TO BE IMPAIRED. HOWEVER, BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED. CORRECTED DATA: TYPE OF INVESTIGATION CODE (ANNEX B): UPDATED 10 INVESTIGATION FINDINGS CODE (ANNEX C): UPDATED TO 3243.

    Additional Manufacturer Narrative · 0

    PER INFORMATION RECEIVED, IT WAS INDICATED THE DEVICE WAS AVAILABLE FOR EVALUATION. HOWEVER, THE DEVICE HAS NOT BEEN RETURNED AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED AT THE TIME OF THE PRODUCT'S RETURN AND EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING SURGERY THAT WHEN THE SURGEON MOVED A ACULOC PLATE POSITION WHILE CONNECTED TO THE LOCKING DRILL GUIDE, THE TIP OF THE DRILL GUIDE BROKE OFF. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT'S BODY. THE SURGERY WAS COMPLETED WITH A REPLACEMENT DEVICE OF THE SAME MODEL WITH NO DELAY. NO OTHER PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752367 2.0MM LOCKING DRILL GUIDE 4MM-32MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-0249 282478

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown