BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HNM SUTURE PASSER DISPOSABLE NEEDLE

    MDR report key: 7934794 · Received October 4, 2018

    Report

    Report Number
    3005031118-2018-00005
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 6, 2018
    Report Date
    October 4, 2018
    Manufacturer
    HNM STAINLESS, LLC DBA HNM MEDICAL
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. PICTURES SENT BY COMPLAINANT CONFIRMS COMPLAINT - NEEDLE BROKEN. ROOT CAUSE UNKNOWN AT THIS TIME. NO DELAY OR CLINICAL COMPLICATIONS.

    Description of Event or Problem · 1

    WHILE DOING PROCEDURE FOR REPAIRING ROTATOR CUFF, PHYSICIAN ON THE LAST PHASE OF PASSING THE SUTURE, THE NEEDLE GOT JAMMED AND BROKE. DOCTOR WAS ABLE TO RETRACT THE NEEDLE ( NO PART REMAINED IN PATIENT AND THE PATIENT DID NOT SUFFERED ANY HARM). WHEN INSPECTING THE SUTURE PASSER, THE DOCTOR RETRACTED THE NEEDLE AND THE DISTAL END WHERE THE NEEDLE GOES OUT WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774368 HNM SUTURE PASSER DISPOSABLE NEEDLE NEEDLE, SUTURE, DISPOSABLE GAB HNM STAINLESS, LLC DBA HNM MEDICAL HNM-49-151385 2116

    Patients

    Seq Age Sex Outcome Treatment
    1