BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX SYSTEM

    MDR report key: 10262733 · Received July 13, 2020

    Report

    Report Number
    1030489-2020-00876
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    July 9, 2020
    Report Date
    November 5, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    FSZ
    UDI-DI
    00721902663444
    PMA / PMN Number
    K993021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: VISUAL AND OPTICAL EXAMINATION IDENTIFIED THAT THE INSIDE SLIT TUBE AND THE OUTSIDE SLIT TUBE HAVE BEEN BROKEN OFF AND WHERE NOT RETURNED FOR ANALYSIS. UNABLE TO DETERMINE ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH STENOSIS SPONDYLOLISTHESIS FOR SPINAL THERAPY. PATIENT DEMOGRAPHICS: GENDER: MALE; AGE: (B)(6). OUTCOME: ALIVE NO INJURY. EVENT WAS INTRA-OP. PROCEDURE USED WAS MAST TLIF. LEVELS IMPLANTED: L4-S1 IT WAS REPORTED THAT THE LIGHT SOURCE IS INSERTED INTO THE METRX TUBE PER ITS IFU. HOWEVER, AFTER ABOUT AN HOUR, THE LIGHT SOURCE COMES APART AT THE END. THE TWO PIECES OF METAL BASICALLY SPLIT IN TWO, WITH ONE PIECE FALLING OFF, EXPOSING THE LIGHT. OF COURSE THE LIGHT IS HOT SO THIS POSES A BURN RISK TO THE PATIENT AS WELL AS THE SURGICAL STAFF. IT ALSO POSES A FIRE HAZARD TO THE PATIENT AND THE OR. LASTLY, THERE IS THE POTENTIAL FOR THE ONE PIECE OF METAL THAT FALLS OFF TO BECOME LODGED INTO THE PATIENT OR FALL INTO THE WOULD BE UNKNOWN TO THE SURGEON AND STAFF. FORTUNATELY IN THIS CASE, NONE OF THESE MORE SERIOUS ISSUES OCCURRED. THE LIGHTS AND THE PIECE OF DISASSOCIATED METAL WERE REMOVED FROM THE PATIENT AND DISCARDED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726377 METRX SYSTEM LIGHT, SURGICAL, CARRIER FSZ WARSAW ORTHOPEDICS 9560757 0562170W 00721902663444

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR