BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM QR DRILL, LAG

    MDR report key: 16284044 · Received February 2, 2023

    Report

    Report Number
    3025141-2023-00023
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    January 11, 2023
    Report Date
    January 31, 2023
    Manufacturer
    ACUMED, LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE BATCH/LOT NUMBER IS UNKNOWN. PER ENGINEERING, THESE DEVICES ARE NOT INTENDED/MEANT TO INTERFACE/INTERACT WITH EACH OTHER ACROSS SYSTEMS. DRILL GUIDE PART NUMBER PL-2196 IS ONLY IN SYSTEMS USED WITH THE DRILL PART NUMBER MS-D35, AND IT IS NOT INCLUDED IN THE SMALL FRAGMENT SET. THE DRILL AND DRILL GUIDE THAT ARE PRESENT IN THE SMALL FRAGMENT SET ARE PART NUMBERS 80-2503 AND 80-2517 RESPECTIVELY. THE DIAMETER OF THE 3.5 CANNULA IN THE PART NUMBER PL-2196 DRILL GUIDE IS THE SAME AS THE PART NUMBER 80-2503 DRILL, AND THEREFORE, THE 80-2503 DRILL WOULD NOT FIT. THE DRILL GUIDES (PL-2196 AND 80-2517) ARE NOT INTENDED TO BE COMPATIBLE ACROSS SYSTEMS. THIS INFORMATION WAS COMMUNICATED TO THE CUSTOMER. THE ROOT CAUSE IS TRACED TO THE USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SURGEON WAS ATTEMPTING TO COMPLETE A PROCEDURE USING THE 3.5 MM DRILL (PART NUMBER 80-2503) FROM THE SMALL FRAGMENT SET. THEY WERE UNABLE TO LOCATE THE APPROPRIATE DRILL GUIDE FROM THE SMALL FRAGMENT SET (PART NUMBER 80-2517), SO THE SURGEON OPTED TO OPEN THE LEMS SET AND USE DRILL GUIDE PART NUMBER PL-2196 FROM THE LEMS SET WHICH IS A SIMILARLY MARKED GUIDE FOR 2.8 AND 3.5 MM DRILLS. THE DRILL AND GUIDE DID NOT INTERFACE APPROPRIATELY, AND THE SURGEON WAS UNABLE TO USE THE DRILL GUIDE IN THE PROCEDURE. IT WAS REPORTED THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE; HOWEVER, INFORMATION REGARDING ANY PATIENT EFFECTS WAS NOT AVAILABLE AND ATTEMPTS TO OBTAIN THIS INFORMATION WERE MADE TO NO AVAIL. THIS REPORT IS RELATED TO REPORT NUMBERS 3025141-2023-00024 AND 3025141-2023-00025 FOR THE OTHER DEVICES INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847426 3.5MM QR DRILL, LAG BIT, DRILL HTW ACUMED, LLC 80-2503

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown