BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM LOCKING DRILL GUIDE 4MM-32MM

    MDR report key: 18937678 · Received March 19, 2024

    Report

    Report Number
    3025141-2024-00267
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 16, 2024
    Report Date
    March 28, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. TWO 2.0MM LOCKING DRILL GUIDE 4MM-32MM AND ONE 2.0MM QUICK RELEASE DRILL WERE RETURNED FOR EVALUATION. SEVERAL UNSPECIFIED ITEMS LIKELY INVOLVED WITH THE ENGAGEMENT WERE NOT RETURNED; THIS NAMELY INCLUDES THE PLATE (WHICH THE DRILL GUIDES THREADED INTO) AND THE TARGETING GUIDE (WHICH THE DRILL GUIDES WERE INSERTED THROUGH). THE RETURNED PRODUCT WAS VISUALLY EXAMINED UNDER MAGNIFICATION. ON ONE OF THE RETURNED LOCKING DRILL GUIDES, THERE WAS A HOLE TORN WITHIN THE THREADING ITSELF; THIS TEAR/DAMAGE SPIRALED ALONG WITH THE THREADING. THE TEAR PROGRESSED ALONG WITH THE THREADING FOR APPROXIMATELY ONE TURN OF THE THREADING IN THE TIP REGION OF THE GUIDE. THIS DAMAGE WAS PRESENT IN THE TROUGH/ROOT OF THE DEVICE'S THREAD. THE OTHER RETURNED LOCKING DRILL GUIDE WAS RETURNED WITH A DRILL EMBEDDED WITHIN THIS GUIDE. THERE WERE OCCASIONAL INSTANCES OF PITTING OR NICKS IN THE PEAK/CRESTS OF THE THREAD FORM AT THE TIP OF THIS GUIDE. AS PREVIOUSLY STATED, THE RETURNED DRILL WAS EMBEDDED IN ONE OF THE RETURNED LOCKING DRILL GUIDES WHICH PARTIALLY OBSCURED THE REGION OF THE DRILL SHAFT STUCK WITHIN THE GUIDE AND MAY INHIBIT VISUAL EVALUATION AS WELL AS SHAFT DIAMETER MEASUREMENT OF THE DRILL. THERE WERE OCCASIONAL INSTANCES OF PITTING OR NICKS ON THE EDGES OF THE FLUTES OF THIS DRILL. MEASUREMENTS FOR 80-0318 DRILL WERE TAKEN IN INCHES. ALL MEASUREMENTS AND AVERAGE WERE WITHIN THE TOLERANCE RANGE. GIVEN THAT UP TO ~2.3 INCHES OF THE SHAFT OF THE DRILL WAS EMBEDDED IN ONE OF THE GUIDES (AS THE DRILL WAS RETURNED STUCK IN THE GUIDE), THE MEASUREMENTS WERE TAKEN FROM THE ~1.84 INCHES OF EXPOSED SMOOTH SHAFT. A FUNCTIONALITY TEST SPECIFICALLY FOR GUIDE-ON-PLATE ENGAGEMENT OF THE GUIDE THAT FAILED THE REPORTED ENGAGEMENT IN THE FIELD WAS NOT CONDUCTED. THE GUIDE THAT HAD DIFFICULTY WITH THE REPORTED GUIDE-ON-PLATE ENGAGEMENT WAS DAMAGED AS PREVIOUSLY STATED TO A POINT WHERE IT WOULD NOT BE FEASIBLE TO ATTEMPT FURTHER SIMILAR ENGAGEMENTS. CONDUCTING USAGE TESTING WOULD RISK DAMAGING THE RETURNED LOCKING DRILL GUIDE FURTHER. A FUNCTIONALITY TEST SPECIFICALLY FOR DRILL-ON-GUIDE ENGAGEMENT FAILURE COULD NOT BE CONDUCTED AS THE DRILL AND ONE GUIDE WERE RETURNED WHOLLY STUCK TOGETHER. IT WAS NOT POSSIBLE TO REMOVE THE DRILL FROM THE GUIDE TO TEST THE ENGAGEMENT. IT WAS NOT POSSIBLE TO COMPREHENSIVELY INVESTIGATE THIS INCIDENT WITHOUT ALL RELEVANT ITEMS PRESENT. THIS SITUATION FUNDAMENTALLY INVOLVES PART FAILURES FROM A THREAD-ON-THREAD ENGAGEMENT (I.E., THREADING THE GUIDE INTO THE PLATE) IN WHICH THE FIELD ONLY RETURNED HALF OF THE RELEVANT PARTS IN THAT ENGAGEMENT (I.E., JUST THE GUIDES, NOT THE PLATE). THE FIELD INCIDENT OF DRILL-IN-GUIDE ENGAGEMENT FAILURE WAS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. THE DRILL AND GUIDE CANNOT BE SEPARATED FOR FURTHER EVALUATION. HOWEVER, BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED. CORRECTED DATA: MEDICAL DEVICE PROBLEM (ANNEX A): UPDATED TO 2919. INVESTIGATION FINDINGS CODE (ANNEX C): UPDATED TO 180. INVESTIGATION CONCLUSION CODE (ANNEX D): UPDATED TO 4315.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS CURRENTLY PENDING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    1 OF 3 IT WAS REPORTED DURING A WRIST FRACTURE SURGERY, THE SURGEON PUT A 2.0MM DRILL GUIDE TO THE PLATE THROUGH THE TARGETING GUIDE. THE FIRST DRILL GUIDE THREADS BROKE WHEN THE SURGEON TIGHTENED IT. THE NEXT DRILL GUIDE GOT STUCK. THE SURGEON OPENED ANOTHER ACU-LOC 2 INSTRUMENT SET AND NEW DRILL GUIDES. THE SURGERY WAS COMPLETED AFTER A 20-MINUTE DELAY. THERE WERE NO OTHER ADVERSE PATIENT CONSEQUENCES REPORTED. THERE ARE 3 RELATED REPORT NUMBERS FOR THIS EVENT 3025141-2024-00267 THROUGH 3025141-2024-00269.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486109 2.0MM LOCKING DRILL GUIDE 4MM-32MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-0249 386983

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown