BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL SHARP

    MDR report key: 8703931 · Received June 17, 2019

    Report

    Report Number
    1723170-2019-03428
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 20, 2019
    Report Date
    August 26, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE AWL SHARP (LOT# 190114) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND PHYSICAL DAMAGE. THERE WAS IMPACT MARKS AT THE BACK END OF THE INSTRUMENT WHICH WERE CAUSING THE FIT ISSUES. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. 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.

    Additional Manufacturer Narrative · 1

    UDI NOT AVAILABLE FOR THIS INSTRUMENT. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE. ADDITIONAL INFORMATION: THE AWL SHARP HAS BEEN RECEIVED BY THE MANUFACTURER. HOWEVER, ANALYSIS HAS NOT BEEN COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PROCEDURE TYPE WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). THERE WAS NO DELAY OR IMPACT TO PATIENT OUTCOME.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE AWL SHARP WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE INSTRUMENTS WERE ABLE TO BE VERIFIED AND USED. IT WAS DIFFICULT TO USE BECAUSE THE TRACKER WOULD NOT SPIN. IT WAS SUSPECTED THAT A SPINAL HANDLE WAS USED ON THE INSTRUMENT CAUSING DAMAGE TO THE COLLET WHERE IT INTERFACED WITH THE HANDLE. WHEN INSERTING THE DAMAGED PIECE THROUGH THE TRACKER, IT WOULD BIND UP. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS WAS IDENTIFIED DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499190 AWL SHARP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734678 190114

    Patients

    Seq Age Sex Outcome Treatment
    1