BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS TRANSLATIONAL SCREWS AND INSTRUMENT

    MDR report key: 21215886 · Received January 23, 2025

    Report

    Report Number
    1030489-2025-00311
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    May 1, 2023
    Report Date
    January 23, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HWJ
    UDI-DI
    00613994236098
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS # (B)(4): PART # 7080911, LOT# DC09F118 VISUAL AND OPTICAL EXAMINATION IDENTIFIED THAT THE TIP OF THE AWL HAS BEEN SHEARED OFF. THE TIP OF THE AWL IS BENT FROM WHAT APPEARS TO BE BEND STRESS OVERLOAD. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 USER FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A FIXED ANGLE AWL USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN. TIP BROKE AFTER MANY USAGES. IT HAS BEEN USED IN PRIOR SURGERIES/ PROCEDURE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489593 ATLANTIS TRANSLATIONAL SCREWS AND INSTRUMENT AWL HWJ MEDTRONIC SOFAMOR DANEK USA, INC 7080911 DC09F118 00613994236098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown