BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX SYSTEM

    MDR report key: 19526389 · Received June 13, 2024

    Report

    Report Number
    1030489-2024-00665
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    June 7, 2024
    Report Date
    August 14, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    UDI-DI
    00721902974816
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E: INITIAL REPORTER DETAILS ARE UNKNOWN MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: PART # 9561524, LOT # MY16A002, VISUAL INSPECTION REVEALED THE FLEX ARM WAS RETURNED WITH NO MISSING OR DISASSEMBLED COMPONENTS. FUNCTIONAL EVALUATION CONFIRMED THE HANDLE ON THE BIK KNUCKLE WAS ABLE TO BE TIGHTENED AND LOOSENED BUT THE FLEX ARM WAS NOT ABLE TO MAINTAIN THE POSITION ONCE TIGHTENED. THE SMALL KNUCKLE WILL NOT TIGHTEN DUE TO THE BROKEN HANDLE. THE HANDLE APPEARS TO BE BROKEN FROM EXCESSIVE FORCE PLACED ON THE INSTRUMENT DURING USE AND THE INTERNAL LOCKING MECHANISM OF THE BIG KNUCKLE SEEMS TO BE WORN FROM REPEATED USE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A FLEX ARM TO BE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE FLEX ARM WILL NO LONGER TIGHTEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THE PRODUCT WAS USED MULTIPLE TIMES. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185247 METRX SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 9561524 MY16A002 00721902974816

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown