BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T8 STICK FIT HEXALOBE DRIVER

    MDR report key: 16850936 · Received May 2, 2023

    Report

    Report Number
    3025141-2023-00296
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 27, 2023
    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 PART NUMBER 80-0318 "2.0MM QUICK RELEASE DRILL" AND 80-0759 "T8 STICK FIT HEXALOBE DRIVER" WERE RETURNED FOR EVALUATION. THE SCREW INVOLVED WHEN THE DRIVER BROKE WAS NOT RETURNED. THE RETURNED DEVICES WERE EXAMINED WITH MAGNIFIED PHOTOGRAPHY. OBSERVED PHENOMENA INCLUDED: [DRILL] BROWN DISCOLORATION/SPOT WAS PRESENT ON FLAT SURFACE OF THE CONNECT FEATURE.THE TWO FLUTES OF THE RETURNED DRILL HAD BEEN TWISTED SUCH THAT THEIR ROTATION ABOUT THE AXIS OF THE DEVICE WAS REVERSED. THIS CLOCKWISE/COUNTERCLOCKWISE REVERSAL HAPPENED TWICE ALONG THE SHAFT OF THE FLUTED SECTION. THE DRILL ITSELF WAS NOT BENT. THE EDGES OF THE DRILL FLUTE WERE WORN/CHIPPED AT VARIOUS POINTS. [DRIVER] BROWN DISCOLORATION WAS PRESENT NEAR LASER MARKINGS. THE BROWN EPOXY BAND ON THIS INSTRUMENT IS PARTIALLY WORN, WITH A SEGMENT OF THE BAND MISSING. THE TIP OF THE DRIVER HAD BROKEN; BOTH THE MAIN BODY OF THE DRIVER AND THE TIP WERE RETURNED. THE TIP WAS APPROXIMATELY 0.1320 INCHES LONG. THE FRACTURE SURFACE WAS HIGHLY OBLIQUE TO THE AXIS OF THE DEVICE. IT IS TEXTURED WITH NO SIGN OF NECKING/DUCTILITY. REGARDING THE RETURNED DRILL, IT IS UNCLEAR WHY THE FLUTES OF THE DRILL WERE TWISTED AS NOTED IN THE INVESTIGATION. UPON FURTHER INVESTIGATION, OF THE 30 COMPLAINTS REPORTED IN THE PREVIOUS 2 YEARS, THIS IS THE FIRST COMPLAINT REPORTING THIS DRILL DEFORMING DURING USE. NO TREND IS CURRENTLY BEING OBSERVED. REGARDING THE RETURNED DRIVER, THE CHARACTERISTICS OF THE TIP BREAKAGE AND FRACTURE SURFACE SUGGEST TORSIONAL FAILURE WITH A POTENTIAL OFF-AXIS LOADING COMPONENT. BRITTLE FAILURE OF DRIVERS WOULD POTENTIALLY OCCUR IN AN OVER-TORQUING SCENARIO. THE INSTRUCTIONS FOR USE PROMPTS THE USER TO INSPECT INSTRUMENTS BEFORE USE. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING ACU-LOC 2 SURGERY, THE DRIVER TIP BROKE. THE SURGEON WAS ABLE TO REMOVE THE DRIVER TIP. ADDITIONALLY, IT WAS REPORTED THE DRILL DEFORMED DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED, AND THIS ISSUE DID NOT PROLONG THE PROCEDURE. THIS REPORT IS RELATED TO REPORT NUMBERS 3025141-2023-00297 AND 3025141-2023-00298 FOR THE DRILL AND SCREW INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799814 T8 STICK FIT HEXALOBE DRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-0759 530525

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown