BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM LOCKING DRILL GUIDE 4MM-32MM

    MDR report key: 20708571 · Received November 18, 2024

    Report

    Report Number
    3025141-2024-00718
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 22, 2024
    Report Date
    December 2, 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

    THE REPORTED 2.0MM LOCKING DRILL GUIDE 4MM-32MM WAS RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE 2.0MM LOCKING DRILL GUIDE 4MM-32MM (PART NUMBER 80-0249, BATCH NUMBER 343832) WAS EXAMINED VISUALLY UNDER MAGNIFICATION. THE END OF THE LOCKING DRILL GUIDE WAS BROKEN OFF. 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 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 AFTER A 10-MINUTE DELAY. NO OTHER PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2620093 2.0MM LOCKING DRILL GUIDE 4MM-32MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-0249 343832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown