BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE KIT, NO NEEDLES

    MDR report key: 13459122 · Received February 4, 2022

    Report

    Report Number
    1526439-2022-00184
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    September 14, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NDN
    UDI-DI
    10705034209630
    PMA / PMN Number
    K060300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: REPORTER'S PHONE NUMBER: (B)(6). A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE CONFIDENCE KIT, NO NEEDLES (P/N: 283913000, LOT #: 317825) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, HYDRAULIC PUMP, CEMENT RESERVOIR AND CEMENT MIXER WERE RETURNED FROM THE KIT. THE CEMENT INSIDE THE RESERVOIR WAS OBSERVED TO BE HARDENED. NO ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICES THAT COULD IMPACT THE DEVICE FUNCTIONALITY. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT COULD NOT BE PERFORMED ON THE COMPLAINT DEVICE DUE TO THE HARDENED CEMENT. NO DIFFICULTIES ENGAGING AND DISENGAGING THE RECTUS CONNECTOR AND THE QUICK-CONNECT FEATURE OF THE CEMENT RESERVOIR CONNECTION WERE DETECTED. THE RETAIN SAMPLES TESTING WAS PERFORMED ON THE LOT# 9781015. THE RESULT OF THE TESTING REVEALED NO DEVIATIONS. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE INTERNAL COMPONENTS OF THE PUMP AND THE CONNECTOR WERE INACCESSIBLE WITHOUT DESTRUCTION OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE NOTED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE CONFIDENCE KIT, NO NEEDLES (P/N: 283913000, LOT #: 317825). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THERE IS A POSSIBILITY THE CEMENT MAY HAVE SOLIDIFIED PREMATURELY DUE TO THE MANNER WITH WHICH IT WAS STORED AND OTHER ENVIRONMENTAL FACTORS THAT MIGHT HAVE AN IMPACT ON THE CEMENT¿S SETTING TIME. THE CONFIDENCE SPINAL CEMENT SYSTEM KIT¿S INSTRUCTIONS FOR USE (IFU-0902-90-055 REV. 8) STATES THAT THE CEMENT SHOULD BE STORED UNOPENED IN ITS ORIGINAL PACKAGING, IN A DRY, CLEAN PLACE AWAY FROM LIGHT, AT A MAXIMUM TEMPERATURE BETWEEN 41° F (5° C) AND 77° F (25° C). WORKING TIME AT OPERATING ROOM AND MATERIAL TEMPERATURE OF 20 DEGREES CELSIUS IS 9 MINUTES. THE HANDLING CHARACTERISTICS AND SETTING TIME CAN VARY IF THE PRODUCT HAS NOT BEEN FULLY EQUILIBRATED AT 68° F (20° C) BEFORE USE. THE UNOPENED PRODUCT SHOULD BE STORED AT 68° F (20° C) FOR A MINIMUM OF 24 HOURS BEFORE USE. NO OTHER POTENTIAL DEFECTS WERE OBSERVED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 283913000. LOT NUMBER: 317825. IT WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 16.07.2021. QTY: (B)(4). CEMENT NUMBER: PRODUCT CODE : 183901001 / BATCH NUMBER : 9781015. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 · 0

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, A NEEDLE PLACED IN L1 CLOGGED SO ADDITIONAL NEEDLE NEEDED TO BE PLACED CONTRALATERALLY. ALSO, WATER LEAKED FROM THE CONNECTOR. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) CONFIDENCE KIT, NO NEEDLES THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421805 CONFIDENCE KIT, NO NEEDLES CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SPINE INC 283913000 317825 10705034209630

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown