BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HNM MEDICAL KERRISON

    MDR report key: 7847000 · Received September 5, 2018

    Report

    Report Number
    3005031118-2018-00003
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    November 3, 2016
    Report Date
    September 4, 2018
    Manufacturer
    HNM STAINLESS, LLC DBA HNM MEDICAL
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS NOT INITIALLY REPORTED AS THERE WAS NO CLINICAL COMPLICATIONS. THIS CUSTOMER COMPLAINT WAS RE-EVALUATED IN (B)(6) 2018 TO SEE IF THE EVENT WERE TO REOCCUR COULD A SERIOUS INJURY OCCUR. SINCE A MALFUNCTION OF THIS TYPE MAY RESULT IN EITHER COMPLICATIONS OR A PROLONGED PROCEDURE, A DECISION WAS MADE TO FILE THIS AS AN MDR. INVESTIGATION CONCLUSION: THIS ITEM IS A DELICATE PRODUCT WITH A THIN FOOTPLATE WHICH IS SPECIFICALLY DESIGNED FOR SMALL BONES IN THE CERVICAL AREA. ONE OF THE IMPORTANT ASPECTS OF USING THIS PRODUCT IS NOT TO TWIST OR PRY THE INSTRUMENT WHILE CUTTING THE BONE. MOREOVER PRODUCT CANNOT BE USED ON LARGER BONES. PRODUCT WAS USED UNINTENDEDLY OR THE PRODUCT FELL ON THE FLOOR OR ON STEEL TABLE AND THE THIN FOOT PLACE GOT ALL THE FORCE OF IMPACT IN THAT SMALL AREA AND AS A RESULT IT CRACKED. THE PRODUCT IS VERY DURABLE FOR NORMAL INTENDED USE AGAINST ANY PRESSURE, STRESS AND IS VERY HARD AND DIFFICULT TO BREAK. BUT IT IS VULNERABLE TO SHOCK THOUGH - IMPACT AGAINST A HARD OBJECT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, HNM'S (B)(6) REPRESENTATIVE REPORTED A BROKEN KERRISON RONGEUR - CATALOG # 1-57-0554. ITEM WAS PURCHASED ON (B)(6) 2014. EVENT DESCRIPTION: THE TIP BROKE OFF IN THE SPINAL CANAL DURING SURGERY. NO CLINICAL COMPLICATIONS. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689092 HNM MEDICAL KERRISON SPURLING KERRISON RONGEUR HTX HNM STAINLESS, LLC DBA HNM MEDICAL HNM-1-57-0554 C3/13

    Patients

    Seq Age Sex Outcome Treatment
    1