BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING HANDLE 80IN-LB

    MDR report key: 20200578 · Received September 12, 2024

    Report

    Report Number
    1526439-2024-02373
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 22, 2024
    Manufacturer
    DEPUY SPINE INC
    Product Code
    LXH
    UDI-DI
    10705034467399
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL 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. ADDITIONAL NARRATIVE: H3, H6: A REVIEW OF THE RECEIVING INSPECTION TORQUE LIMITING HANDLE 80IN-LB WAS CONDUCTED IDENTIFYING THAT LOT GB120330 RELEASED IN ONE BATCH. SUPPLIER: GAUTHIER BIOMEDICAL, INC. ¿ BATCH1: RELEASED ON 12 AUGUST 2019 WITH NO DISCREPANCIES THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE RECEIVED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT TORQUE LIMITING HANDLE 80IN-LB , THE PROVIDED EVIDENCE WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT OF OVER/UNDER TORQUE & OUT OF CALIBRATION. FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH A PHOTO INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE TORQUE LIMITING HANDLE 80IN-LB WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AUGUST 22, 2024, THE TORQUE LIMITING HANDLE FROM A LOAN SET FAILED INSTRUMENT TORQUE TEST DURING AN INSTRUMENT INSPECTION.THIS REPORT IS FOR A TORQUE LIMITING HANDLE 80IN-LB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479056 TORQUE LIMITING HANDLE 80IN-LB ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE INC GB120330 10705034467399

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown