BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW DRIVER

    MDR report key: 8859528 · Received August 5, 2019

    Report

    Report Number
    1723170-2019-04357
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 20, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. THE EVENT DATE IS NOT KNOWN FROM THE SITE. THE UNIQUE IDENTIFIER WAS NOT KNOWN AT THE TIME OF REPORTING. 510K NUMBER NOT KNOWN AT THE TIME OF REPORTING. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER DATE WAS NOT KNOWN AT THE TIME OF REPORTING. INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITION INFORMATION RECEIVED: LOT NUMBER: 111228, MODEL NUMBER: 9734856, 510K NUMBER: K050438. THE SCREWDRIVER WAS RETURNED TO THE MANUFACTURE FOR EVALUATION. AFTER VISUAL/PHYSICAL EXAMINATION THE REPORTED ISSUE WAS CONFIRMED. THE TIP OF THE RETURNED DRIVER IS TWISTED AND BROKEN OFF. PHYSICAL DAMAGED WAS OBSERVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A CASE IN THE WEEK OF 7/22-7/26 (DATE UNKNOWN) THAT WHEN THE HEALTHCARE PROFESSIONAL (HCP) BEGAN PLACING A SCREW, THE TIP OF THE SCREW DRIVER BROKE OFF INTO THE PATIENT. THE HCP WAS ABLE TO REMOVE THE TIP FROM THE PATIENT AND CONTINUE THE SURGERY. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653745 SCREW DRIVER INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734856

    Patients

    Seq Age Sex Outcome Treatment
    1