BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT TUNNELER

    MDR report key: 7330970 · Received March 12, 2018

    Report

    Report Number
    9612007-2018-00003
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    January 24, 2018
    Report Date
    February 16, 2018
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K932273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 27MARCH2018 WITH THE FOLLOWING: ISSUE TO TAKE OFF THE HANDLE FROM TUNNELER; NEED TO FORCE BETWEEN THE TUBE AND HANDLE. "THIS HAPPENED YET BUT NOT SO HARD THAT IT WAS THIS TIME". NEED TO USE FORCEPS TO TAKE OFF THE HANDLE WHICH EXPLAIN METAL RESIDUES (FROM THE TUBE). INVESTIGATION COMPLETED 13APR2018: TWO PRODUCTS RECEIVED: TUNNELER N°1: STAINLESS STEEL TUBING DEFORMED, HANDLE SLIGHTLY DEFORMED, MARKS LIKELY MADE BY APPLIERS NOTED ON THE TUBING NEAR THE HANDLE. THE TUBING TIP SPECIFIC SHAPE FOR HANDLE PLACEMENT IS DEFORMED. TUNNELER N°2: STAINLESS STEEL TUBING DEFORMED, CUT AND PINCHED, BROKEN HANDLE WITH THE BROKEN TUBING TIP STUCK INSIDE. THE TIP SHAPE IS NORMAL. DIMENSIONAL TESTING OF THE 2 PRODUCTS DID NOT SHOW ANOMALIES THAT COULD EXPLAIN THE REPORTED PROBLEM. TRYING TO SIMULATE THE PROBLEM BY APPLYING A FORCED ROTATION OF THE HANDLE ON THE TUBE COULD NOT LED TO HANDLE BREAKAGE NOR TO A DISTORTION OF THE TUBE TIP. IT WAS POSSIBLE TO BLOCK THE HANDLE ON THE TUBING ONLY UNDER A HIGH FORCE AND WITH THE TUBING BLOCKED IN THE JAWS OF A VISE (TO PREVENT ROTATION OF THE ASSEMBLY). THE COMPLAINT ALSO REPORTED THE PRESENCE OF METALLIC RESIDUE IN THE SURGICAL HOLE: ADDITIONAL INFORMATION FROM THE HOSPITAL STATED THE METALLIC RESIDUES WERE RELATED TO THE APPLIERS USED TO REMOVE THE HANDLE. THE DEVICE HISTORY RECORDS REVIEW OF REF 990010 LOT 0199886 DID NOT REVEAL ANY ANOMALY. THE COMPLAINT IS VERIFIED; THE TUNNELERS WERE RECEIVED DAMAGED. THE ANALYSIS OF THE MANUFACTURING PROCESS, OF THE DEVICE HISTORY RECORDS AND OF THE RECEIVED PRODUCTS CONCLUDED A MANUFACTURING DEFECT AS UNLIKELY. THE EXACT ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED BY THE INVESTIGATION.

    Description of Event or Problem · 1

    THE 990010 SHUNT TUNNELER WAS DEFECTIVE. "MISMATCHING OF THE TUNNELER AFTER THE TUNNELISATION DURING SURGERY" WAS REPORTED. THERE WAS A NEED TO FORCE THE DEVICE. METAL RESIDUES IN THE SURGICAL HOLE NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174078 SHUNT TUNNELER VALVE ACCESSORIES JXG INTEGRA NEUROSCICENCS IMPLANTS SA 0199886

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR