BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLO VEST TALL-INTL

    MDR report key: 7068680 · Received November 29, 2017

    Report

    Report Number
    1526439-2017-50025
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 1, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    IQF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). A HARD PLASTIC CONNECTOR AND A THREADED BOLT WERE RETURNED FOR EVALUATION. THE HARD PLASTIC COMPONENT IS MISSING A THREADED WASHER. THIS WASHER IS ATTACHED TO THE THREADED BOLT AND CANNOT BE REMOVED. THE HARD PLASTIC CONNECTOR FEATURES DAMAGE TO THE WALL OF THE RECESSED AREA WHERE THE WASHER USED TO BE. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A TREND ANALYSIS WAS CONDUCTED. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE OF THE PLASTIC CONNECTION COMPONENTS BECOMING LOOSE COULD NOT BE DETERMINED FROM THE SAMPLES AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE MAY BE FORCES PLACED ON THE BOLT AND WASHER OF THE CONNECTOR RESULTING IN THE PIECES BEING FORCED FROM THE PLASTIC CONNECTOR, DAMAGING THE CONNECTOR IN THE PROCESS. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCOUNT NAME: (B)(6) HOSPITAL THE REPORTED PRODUCT WAS USED IN HANGMAN FRACTURE SURGERY WITH THE VEST (AF102W) ON (B)(6) 2017. APPROXIMATELY TEN DAYS AFTER THE SURGERY, THE CONNECTING SECTION BY THE USE OF A CLAMP AND A SCREW HAD BECOME LOOSE. SO, THE SURGEON PERFORMED SPINE FIXATION, SET UP THE VEST AGAIN WITHOUT A PROBLEM ON (B)(6). IT WAS REPORTED THAT THE CLAMP COULD HOLD THE VEST SECURELY. THE SURGERY WAS DELAYED BY 60 MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849000 AIRFLO VEST TALL-INTL UNKNOWN IQF DEPUY SYNTHES SPINE 059830

    Patients

    Seq Age Sex Outcome Treatment
    1