BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM CANN. QUICK RELEASE DRIVER TIP

    MDR report key: 14312454 · Received May 6, 2022

    Report

    Report Number
    3025141-2022-00119
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 6, 2022
    Report Date
    April 27, 2022
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE RETURNED PRODUCTS WERE INSPECTED UNDER MAGNIFICATION. UNDER MAGNIFICATION, THE BATCH NUMBER FOR THE MEDIUM RATCHETING DRIVER HANDLE (P/N 80-0663) WAS CONFIRMED AS 545806, AND THE BATCH NUMBER FOR THE 1.5MM CANN. QUICK RELEASE DRIVER TIP (P/N HT-0915) WAS CONFIRMED AS 537292. THE MICRO ACUTRAK SCREW USED WITH THESE PRODUCTS DURING THE PROCEDURE WAS NOT RETURNED. UPON INSPECTION, THERE WAS MINIMAL WEAR SEEN ON EITHER RETURNED PART. THE DRIVER TIP SHOWED SOME MINOR SCRAPES AT THE QUICK RELEASE END. NO OTHER NOTABLE SIGNIFICANT DAMAGE WAS OBSERVED. AFTER RECEIVING THE RETURNED PRODUCTS, THE DRIVER TIP AND HANDLE WERE ASSEMBLED. WHEN ASSEMBLED, THE DRIVER SCRAPED AGAINST THE SIDES OF THE DRIVER HANDLE CONNECTOR. THE DRIVER WAS ABLE TO BE REMOVED A FEW TIMES WITH THIS SCRAPING PRESENT BEFORE IT BECAME STUCK IN THE CONNECTOR. WITH MORE SIGNIFICANT FORCE APPLIED TO THE CONNECTOR ON THE HANDLE, THE DRIVER BECAME DISLODGED. AN ADDITIONAL SAMPLE OF HT-0915 FROM THE ENGINEERING LAB WAS ASSEMBLED WITH THE RETURNED DRIVER HANDLE AND THE SAME SCRAPING AND DIFFICULTY DISENGAGING FROM THE HANDLE WAS OBSERVED. WITHOUT DESTRUCTIVE TESTING IT WAS NOT POSSIBLE TO OBSERVE THE INTERNAL MECHANISMS OF THE DRIVER HANDLE AND THE POTENTIAL CAUSE OF THE CONNECTION/DISCONNECTION ISSUE FROM THE DRIVER. THEREFORE, NO DEFINITIVE CONCLUSION COULD BE MADE.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE SURGEON HAD DIFFICULTY WITH DISENGAGING THE DRIVER TIP FROM THE SCREW. THE SURGEON WAS CONCERNED THE ATTEMPTS TO DISENGAGE WOULD CAUSE A FRACTURE OF THE BONE BRIDGE. ADDITIONALLY, THE DRIVER TIP WOULD NOT RELEASE FROM THE DRIVER HANDLE. THE PROCEDURE WAS COMPLETED, AND THE TIME TO DISENGAGE THE SCREW FROM THE DRIVER ADDED ONLY 2-3 MINUTES TO THE PROCEDURE. THIS REPORT IS RELATED TO REPORT NUMBERS 3025141-2022-00120 AND 3025141-2022-00121 WHICH ARE FOR THE OTHER DEVICES INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098886 1.5MM CANN. QUICK RELEASE DRIVER TIP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC HT-0915 537292

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown