BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HNM SUTURE PASSER DISPOSABLE NEEDLE

    MDR report key: 7871354 · Received September 12, 2018

    Report

    Report Number
    3005031118-2018-00004
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Report Date
    September 12, 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

    THE NEEDLES (2) BROKE DURING SUTURING OF A ROTATOR CUFF. NO DELAY OR CLINICAL COMPLICATIONS. SUSPECT DEVICES HAVE NOT BEEN RETURNED YET.

    Description of Event or Problem · 1

    DURING A SUTURE PROCESS OF A ROTATOR CUFF RECONSTRUCTION, 2 DISPOSABLE NEEDLE BROKE DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708597 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