BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM LOCKING DRILL GUIDE 4MM-32MM

    MDR report key: 20311246 · Received September 26, 2024

    Report

    Report Number
    3025141-2024-00661
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 12, 2024
    Report Date
    November 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

    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 329365) WAS EXAMINED VISUALLY UNDER MAGNIFICATION. THE END THREAD OF THE LOCKING DRILL GUIDE HAS BEEN SHEARED OFF. UNDER MAGNIFICATION THE FRACTURE SURFACE IS BRITTLE, WITH FRAGMENTS OF THE THREADS HANDING OFF THE TIP. THIS ROUGH FRACTURE SURFACE WAS INDICATIVE OF A SINGLE EXCESSIVE LOAD. A FAILURE SUCH AS THIS USUALLY OCCURS WITH AN OFF-AXIS EXCESSIVE LOADING OF THE DRILL GUIDE WHILE THREADED IN THE PLATE OR IF THE GUIDE WAS CROSS THREADED DURING INSERTION AND OVER TORQUED. THE MISSING THREADS WERE NOT RETURNED. 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

    THE REPORTED 2.0MM LOCKING DRILL GUIDE 4MM-32MM WAS NOT RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS FOR 2.0MM LOCKING DRILL GUIDE 4MM-32MM (PART NUMBER 80-0249, BATCH NUMBER 329365) WERE REVIEWED, AND NO ANOMALIES WERE FOUND. BASED ON THE INFORMATION RECEIVED, 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
    1098488 2.0MM LOCKING DRILL GUIDE 4MM-32MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-0249 329365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown