BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURELOK MIS 3L

    MDR report key: 11359694 · Received February 22, 2021

    Report

    Report Number
    3005739886-2021-00012
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 27, 2021
    Report Date
    January 27, 2021
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    LXH
    UDI-DI
    00840019920179
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION - THE INSERTER WAS RETURNED FOR EVALUATION WITH THE GOLD KNOB FROZEN IN THE FULLY COUNTER-CLOCK-WISE DIRECTION. THE LASER MARKINGS ARE CRISP AND LEGIBLE. GIVEN THE INFORMATION PROVIDED, IT IS LIKELY THE SURGEON FROZE THE KNOB WHEN USING THE GREEN HANDLE TORQUE DRIVER BY SUPPLYING MORE COUNTER-CLOCK-WISE TORQUE THAN THAT HANDLE IS CAPABLE OF SUPPLYING IN THE CLOCK-WISE DIRECTION DUE TO THE TORQUE LIMIT FEATURE.THE KNOBWAS ABLE TO BE LOOSENED DURING THIS INVESTIGATION USING A NON-TORQUE LIMIT DEVICE. ONCE LOOSENED, THE INSERTER FUNCTIONS AS INTENDED. REVIEW OF DEVICE HISTORY RECORDS FOUND TEN (10) PIECES OF LOT 00188PT WERE RELEASED FOR DISTRIBUTION ON 10/19/2020 WITH NO DEVIATION OR ANOMALIES. NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME DUE TO THE LIKELIHOOD THE FAILURE CAN BE ATTRIBUTED TO AN EXCESSIVE LOAD (COUNTER-CLOCK-WISE TORQUE) APPLIED TO THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED UTILIZING THE SURELOK MIS 3L SYSTEM. THE FIRST ROD WAS LOADED NORMALLY ON TO THE INSERTER AND THEN SUCCESSFULLY IMPLANTED USING THE INSERTER. THE SURGEON HAD DIFFICULTY REMOVING THE INSERTER FROM THE ROD USING THE GREEN TORQUE LIMITED DRIVER, BUT ULTIMATELY WAS ABLE TO FREE IT WITH NO NEGATIVE IMPACT TO THE PATIENT OR IMPLANTS. ON THE BACK TABLE THE SCRUB TECH NOTED THAT THE GOLD NOB ON THE INSERTER WAS NOT TURNING. THEY USED STERILE INSTRUMENTS TO TRY TO TURN THE KNOB, BUT WERE UNABLE TO GET ANY MOVEMENT. THE SECOND ROD WAS IMPLANTED USING A NORMAL OPEN ROD INSERTER, NO ATTEMPT TO USE THIS PART WAS MADE AGAIN. THERE WAS NO INJURY TO THE PATIENT OR DELAY TO THE PROCEDURE REPORTED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION - UNKNOWN. REPORTER OCCUPATION - OTHER; SALES REPRESENTATIVE . EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED UTILIZING THE SURELOK MIS 3L SYSTEM. THE FIRST ROD WAS LOADED NORMALLY ON TO THE INSERTER AND THEN SUCCESSFULLY IMPLANTED USING THE INSERTER. THE SURGEON HAD DIFFICULTY REMOVING THE INSERTER FROM THE ROD USING THE GREEN TORQUE LIMITED DRIVER, BUT ULTIMATELY WAS ABLE TO FREE IT WITH NO NEGATIVE IMPACT TO THE PATIENT OR IMPLANTS. ON THE BACK TABLE THE SCRUB TECH NOTED THAT THE GOLD NOB ON THE INSERTER WAS NOT TURNING. THEY USED STERILE INSTRUMENTS TO TRY TO TURN THE KNOB, BUT WERE UNABLE TO GET ANY MOVEMENT. THE SECOND ROD WAS IMPLANTED USING A NORMAL OPEN ROD INSERTER, NO ATTEMPT TO USE THIS PART WAS MADE AGAIN. THERE WAS NO INJURY TO THE PATIENT OR DELAY TO THE PROCEDURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253807 SURELOK MIS 3L ROD INSERTER LXH PRECISION SPINE, INC. 63-SP-9005 00188PT 00840019920179

    Patients

    Seq Age Sex Outcome Treatment
    1