BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM CANN. QUICK RELEASE DRIVER TIP

    MDR report key: 15279951 · Received August 23, 2022

    Report

    Report Number
    3025141-2022-00266
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    May 19, 2022
    Report Date
    August 22, 2022
    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 DRIVER WAS EXAMINED UNDER MAGNIFICATION. UNDER MAGNIFICATION, THE BATCH NUMBER FOR THE RETURNED 1.5MM CANN. QUICK RELEASE DRIVER TIP WAS CONFIRMED AS 253190. A TORSIONAL FRACTURE PATTERN WAS IDENTIFIED AT THE HEX PORTION OF THE DRIVER. THE DRIVER TIP WAS MEASURED TO DETERMINE THE LOCATION OF FRACTURE AND APPROXIMATE THE AMOUNT OF MATERIAL MISSING. THE DRIVER MEASURED 3.4185 INCHES, INDICATING THAT APPROXIMATELY .0815 INCHES HAD BROKEN OFF THE TIP. A TORSIONAL FRACTURE PATTERN LIKELY INDICATES AN EXCESSIVE TWISTING LOAD ABOUT THE DRIVER'S CENTRAL AXIS; HOWEVER, DUE TO UNKNOWN PROCEDURAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE PROCEDURE, WHEN THE SURGEON TRIED TO INSERT THE SCREW, THE TIP OF THE DRIVER BROKE. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE OF THE DRIVER TIP. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2022-00267 FOR THE SCREW INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828927 1.5MM CANN. QUICK RELEASE DRIVER TIP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC HT-0915 253190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown