BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18.0MM, MINI ACUTRAK 2® BONE SCREW

    MDR report key: 15056607 · Received July 19, 2022

    Report

    Report Number
    3025141-2022-00229
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    June 21, 2022
    Report Date
    July 22, 2022
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    PMA / PMN Number
    K944330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE REPORTED SCREW WAS RETURNED FOR EVALUATION. THE DRIVER INVOLVED IN THIS EVENT (REPORT NUMBER 3025141-2022-00230) WAS NOT RETURNED. THE EXAMINATION PERFORMED WAS FOR THE RETURNED SCREW. THE RETURNED PART WAS EXAMINED WITH MAGNIFICATION. VISUAL INSPECTION REVEALED SCREW WEAR. THE SCREW EXHIBITED MODERATE TO HEAVY WEAR NEAR THE DRIVE FEATURE INCLUDING SURFACE SCRATCHES/NICKS/DENTS AS WELL AS COATING WEAR WITH UNDERLYING MATERIAL VISIBLE. AN EXAMINATION OF FUNCTIONALITY WAS CONDUCTED; TEST ENGAGEMENTS WERE MADE BETWEEN THE RETURNED SCREW AND OTHER SUITABLE HD-0020 2.0MM DRIVERS IN THE ENGINEERING LAB. THREE DRIVERS WERE TESTED WITH ALL DRIVERS FAILING TO ENGAGE WITH THE RETURNED SCREW. FURTHER TESTING WAS DONE WITH TWO HT-1120 DRIVERS FROM THE ENGINEERING LAB ACUTRAK 2 KIT WITH BOTH DRIVERS FAILING TO ENGAGE WITH THE RETURNED SCREW. THE TWO HT-1120 DRIVERS WERE TEST-ENGAGED WITH TWO 18MM-LENGTH MINI ACUTRAK 2 SCREW FROM THE ENGINEERING LAB KIT, AND BOTH KIT DRIVERS COULD ENGAGE WITH THE KIT SCREWS. THE FUNCTIONALITY TEST REPLICATED THE FIELD EVENT; NONE OF THE TESTED DRIVERS COULD ENGAGE WITH THE RETURNED SCREW, AND IT WAS VERIFIED THAT DRIVERS COULD ENGAGE WITH OTHER 2.0MM HEX FEATURES. IT IS UNCLEAR IF ANY ASPECTS OF THE DRIVER INVOLVED IN THIS EVENT CONTRIBUTED TO THIS DIFFICULTY IN ENGAGING BOTH PARTS; HOWEVER, IT IS LIKELY DUE TO THE INABILITY OF THE RETURNED SCREW TO ENGAGE, AS MULTIPLE OTHER KNOWN-FUNCTIONAL DRIVERS IN THE ENGINEERING LAB SIMILARLY FAILED TO ENGAGE THE SCREW. IT IS LIKELY THAT THE DRIVE FEATURE OF THE RETURNED SCREW IS THE SOURCE OF THE OBSERVED PHENOMENA. HOWEVER, NO DEFINITIVE CONCLUSION CAN BE MADE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE PROCEDURE WHEN THE SURGEON DECIDED WHAT SIZE OF SCREW TO BE USED, THE SURGEON OPENED THE SPECIFIC SCREW - PART NUMER AT2-M18-S AND TRIED TO USE THE 2.0MM CANN. QUICK RELEASE DRIVER TIP (PART NUMBER HT-1120) TO GET THE SCREW IN. IT WAS NOTED THE DRIVER TIP AND THE SCREW DIDN'T MATCH, AND THE "DIAMETER OF THE 18MM MINI SCREW WAS SMALLER THAN IT SHOULD BE". ANOTHER 18MM MINI SCREW WAS OPENED, AND IT WORKED WELL WITH THE DRIVER TIP. HOWEVER; THIS INCIDENT DELAYED THE WHOLE SURGERY ABOUT 1 HOUR, SINCE IN THE VERY BEGINNING, THE ISSUE WAS THOUGHT TO BE WITH THE DRIVER TIP, SO ATTEMPTS HAD BEEN MADE TO FIND ANOTHER DRIVER TIP RESULTING IN THE DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2022-002230 FOR THE DRIVER INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528306 18.0MM, MINI ACUTRAK 2® BONE SCREW SCREW, FIXATION, BONE HWC ACUMED, LLC AT2-M18-S 555539A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female