BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TL REVISION INSTRUMENTS

    MDR report key: 11789027 · Received May 7, 2021

    Report

    Report Number
    1030489-2021-00582
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 16, 2021
    Report Date
    October 13, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    UDI-DI
    00885074226552
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: PRODUCT ANALYSIS # (B)(4): PART #: 8880009, LOT # BM13A012. VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE INSTRUMENT. FUNCTIONAL INSPECTION CONFIRMED THE TORQUE LIMITING DRIVER WAS ABLE ATTACH AND RELEASE A SAMPLE DRIVER BUT DID NO PASS THE TORQUE TEST. THE INSTRUMENT WAS OUT OF RANGE. IT APPEARS THE TORQUE MECHANISM IS WORN FROM REPEATED USE. 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.

    Additional Manufacturer Narrative · 1

    COUNTRY: (B)(6). PMA/510(K)#: CLASS I EXEMPT. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF VERTEBRAL CANAL STENOSIS AT L5/S IN NEED OF L5/S TLIF USED IN SPINAL THERAPY. IT WAS REPORTED THAT WHEN RETIGHTENING SET SCREW WITH A DRIVER THAT COMBINED THE 815-518 SHAFT T25 AND THE 8880009 SO47 TORQUE LIMITING DRIVER, THE TIP OF THE BROKE DURING RETIGHTENING OF THE NON-BREAK SET SCREW OF SOLERA 4.75. THE BROKEN TIP WAS REMOVED FROM THE SURGICAL FIELD. THE EVENT WAS THOUGHT TO HAVE OCCURRED IN THE 4TH ONE OF FIXATION OF ONE INTERVERTEBRAL DISC. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685262 TL REVISION INSTRUMENTS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 8880009 BM13A012 00885074226552

    Patients

    Seq Age Sex Outcome Treatment
    1