BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER2 SCREW EXTENSION, CLOSED

    MDR report key: 6061854 · Received October 27, 2016

    Report

    Report Number
    1526439-2016-10800
    Event Type
    Injury
    Date Received
    October 27, 2016
    Report Date
    October 3, 2016
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT FAILURE IS INDICATED. THE DEPUY SYNTHES SPINE DEVICES HAVE NOT BEEN IMPLICATED IN THE POSTOPERATIVE INFECTION. THE DEPUY SYNTHES SPINE DEVICES ARE SOLD NON-STERILE AND THE CUSTOMER IS RESPONSIBLE FOR THEIR STERILIZATION. A MEDWATCH REPORT WILL BE FILED ON THE EVENT (IE. THE INFECTION) AND THE DEVICES ARE CONSIDERED TO BE CONCOMITANT. 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 · 1

    THE SALES REP. RECENTLY HAD A MEETING WITH THE DIRECTOR OF THE SURGICAL CENTER, STERILIZATION MANAGER AND WITH THE ORTHOPEDICS TEAM. THEY ARE EVALUATING SOME INFECTION CASES THAT THEY HAD WITH 04 PATIENTS AND THE ROOT CAUSE IS NOT CLEAR SO FAR. THEREFORE, AS THEY ARE EVALUATING ALL POSSIBLE CAUSES THEY VERIFIED THEIR INTERNAL PROTOCOLS AND NOTHING WAS CHANGED, THEY KEEP HANDLING AS THE SAME WAY AS BEFORE THIS INFECTIONS APPEAR. THE ONLY EVIDENCE NOTED WAS THAT THE VIPER¿S CANNULA WAS PRESENTING A DIRT ACCUMULATION INSIDE. DUE OF IT, THEY ALSO CHECKED THAT 03 OF THESE 04 PATIENTS USED VIPER IN THEIR SPINE SURGERIES. IS IMPORTANT TO DESCRIBE HERE THAT THIS PRODUCT IS NOT ONLY USED BY THIS HOSPITAL, THE PRODUCT IS STERILIZED AFTER THE USE AND IS RETURNED TO THE WAREHOUSE CENTER AND FURTHER CAN BE SEND TO ANOTHER DIFFERENT HOSPITAL. THE STERILIZATION PROCESS IS DONE BY THE LAST HOSPITAL THAT USED THE INSTRUMENT. DUE THIS DIRT ACCUMULATION INSIDE THE CANNULAS, THE HOSPITAL IS CONCERNING ABOUT THE CORRECT PROCESS OF CLEANING OF THE VIPER¿S CANNULA. PLEASE SEE BELOW SOME POINTS THAT WERE DISCUSSED IN THE MEETING WITH THE SALES REP. AND THE HOSPITAL TEAM: FOR TWO MONTHS THE HOSPITAL IS HAVING CASES OF ACUTE INFECTIONS IN 04 COLUMN PATIENTS, WHERE 03 CASES WERE PATIENTS WHO USED VIPER; THE HOSPITAL OPENED AN INVESTIGATION ABOUT THE EVENT TO IDENTIFY SOME EVIDENCE AND BLOCK NEW CASES; THE NURSE, WHO RECEIVED THE COLUMN MATERIAL IN THE LAST SURGERY AND INSPECTED THE MATERIAL, INFORMED US THAT THE VIPER IS WITH CLEANING AND CONTAMINATION PROBLEMS IN THE CANNULAS AND THEY DIRTY ARRIVED AT THE HOSPITAL; THE HOSPITAL'S INTERNAL INVESTIGATION HAS NOT BEEN COMPLETED SO FAR BUT THEY IDENTIFIED A FAILURE IN THE STERILIZATION PROCESS. THUS, THEY ARE CONCERNING ABOUT THE CLEANLINESS OF THE CANNULA, ONCE IT IS NOT POSSIBLE TO VERIFY THE CLEANING 100 % OF THE PIECES THAT MAKE UP THE CANNULA (INSIDE THE CANNULA FOR EXAMPLE); SINCE THE ACCESS TO THIS PART OF THE MATERIAL IS VERY HARD AND THE CANNULA HAS A VERY STRONG PRESSURE TO ACHIEVE THE OPENING AND IS EXACTLY THE PART THAT WAS DIRTY, THE HOSPITAL REQUESTS TO THE OPERATOR COMPANY A GUIDANCE OF: IS IT POSSIBLE TO DISASSEMBLE THESE INSTRUMENTS, IF YES, HOW IT SHOULD BE DONE; THERE IS A GUIDANCE OF HOW TO CLEAN THE INSTRUMENT; THERE IS A GUIDANCE OF HOW TO CHECK THE INSTRUMENT AFTER CLEANED? SPECIAL POINTS? CHECK LIST: THERE IS AN AMOUNT OF TIME TO USE THESE INSTRUMENTS. THE SALES REP. IS NOT ALLOWED TO KEEP USING THESE INSTRUMENTS UNTIL FIND OUT THE ROOT CAUSE OR SOLVE THE PROBLEM. AS 04 PATIENTS ARE INVOLVED AND WERE REPORTED BY THE HOSPITAL, 04 DIFFERENT COMPLAINTS WILL BE ENTERED. WE NEED THE ANSWERS FROM DEPUY ASAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711874 VIPER2 SCREW EXTENSION, CLOSED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE MI32255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other