BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIALTIS TORQUE LIMITER RATCHET 11,3 NM

    MDR report key: 20918212 · Received December 12, 2024

    Report

    Report Number
    3010938185-2024-00001
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 12, 2024
    Manufacturer
    GAUTHIER BIOMEDICAL, INC.
    Product Code
    LXH
    UDI-DI
    00858325005688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    GAUTHIER BIOMEDICAL, INC. (GBI) IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY GBI AS OF 12/10/24. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, GBI OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA THAT GBI, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THE DEVICE WAS PART OF LOT GB156110 RELEASED APRIL 23, 2024 AND WAS RETURNED TO GBI. THE GBI TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DEVICE SHOWED NO DAMAGE OR DEFECTS. A DIMENSIONAL INSPECTION FOR THE TORQUE LIMITING HANDLE WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A TORQUE TEST WAS PERFORMED ON THE COMPLAINT DEVICE AT GBI. THE TORQUE MEASURED WITHIN THE DESIGN SPECIFICATION (11.3 NM ± 10%). THE DEVICE FUNCTIONED AS INTENDED BY THE DESIGN. THE DEVICE HISTORY RECORD (DHR) OF THE LOT WAS REVIEWED, AND NO DISCREPANCIES WERE FOUND. NO ISSUES HAVE BEEN IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. AS A RESULT, THE EVENT AND ROOT CAUSE APPEAR TO BE UNRELATED TO THE DEVICE IN QUESTION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PEDICLE SCREW BROKE PEDICLE DURING FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF 45 MINUTES. INTRA-OP CT WITH SCREW REPLACEMENT WAS PERFORMED WHEN THE EVENT OCCURRED. AS OTHER MEDICAL INTERVENTION, INTRA-OP CT WITH O-ARM WAS PERFORMED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414185 TRIALTIS TORQUE LIMITER RATCHET 11,3 NM RATCHETING TORQUE LIMITER LXH GAUTHIER BIOMEDICAL, INC. 5161-00-5048 GB156110 00858325005688

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other