BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM QR DRILL, W/ DEPTH MARKS

    MDR report key: 16605838 · Received March 23, 2023

    Report

    Report Number
    3025141-2023-00104
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 22, 2023
    Manufacturer
    ACUMED, LLC
    Product Code
    HTW
    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 DRILL WAS VISUALLY INSPECTED UNDER MAGNIFICATION. ADDITIONALLY, THE OVERALL LENGTH WAS MEASURED TO CONFIRM FRACTURE POINT AND APPROXIMATE HOW MUCH MATERIAL WAS GONE. IT WAS NOTED THE SURFACE WAS NOT AS SMOOTH AND DID NOT SHOW FATIGUE LINES, WHICH IS INDICATIVE OF A SHEAR FORCE BREAK. THE ORIGINAL SPECIFIED LENGTH, PER PRINT, OF THE DRILL IS 5.75 +/- 0.06 AND THE OVERALL LENGTH AFTER FRACTURE WAS FOUND TO BE APPROXIMATELY 5.221 INCHES. REVIEWING THE SURGICAL TECHNIQUE, THE 2.0 MM QUICK RELEASE DRILL (PART NUMBER 80-2378) IS USED IN CONJUNCTION WITH THE 2.0 MM LOCKING DRILL GUIDE (PART NUMBER 80-2371) BY INSERTING THE DRILL THROUGH THE CENTER AND ADVANCING THE DRILL TO DESIRED DEPTH. MISALIGNMENT DURING INSERTION INTO THE DRILL GUIDE OR DIRECTLY DRILLING INTO INCORRECT PLATE HOLE COULD RESULT IN BREAKAGE; HOWEVER, BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN PROCEDURAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED..

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A PROCEDURE, THE DRILL BROKE DURING DRILLING OF THE PATIENT'S DISTAL TIBIA. THE BROKEN PIECE OF THE DRILL COULD NOT BE RETRIEVED AND THEREFORE REMAINS IN THE PATIENT'S BONE. NO FURTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700619 2.0MM QR DRILL, W/ DEPTH MARKS BIT, DRILL HTW ACUMED, LLC 80-2378 554976

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown