BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 2832431 · Received November 14, 2012

    Report

    Report Number
    2953769-2012-00164
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    January 10, 2013
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS PARTS RECEIVED: RECEIPT OF ONE IBT EXPRESS 15/2. NO BLOOD ON THE DEVICE; ALREADY DECONTAMINATED. OBSERVATIONS: DURING FUNCTIONAL ANALYSIS, THE BALLOON WAS INFLATED WITH WATER AND INDICATE THAT NO LEAKAGE HAS OCCURRED. INSERTION IS NOT POSSIBLE, DUE TO THE FACT THAT THE BALLOON NO LONGER DISPLAYS THE BEAKED SHAPE. IT SEEMS TO HAVE BEEN INFLATED AT LEAST ONE TIME. VISUAL ANALYSIS WAS DONE AND IT APPEARS THAT THE IBT IS MEETING THE SPECIFICATION. PROXIMAL BONDING IS NOT TOO THICK. A REVIEW OF THE IN-LINE MEASUREMENT OF BALLOON WALL THICKNESS HAS BEEN PERFORMED AND ALL MEASUREMENTS ARE WITHIN SPECIFICATION. OTHER CONTROLS HAVE BEEN PERFORMED AND IT INDICATES THAT THE IBT MEETS ALL SPECIFICATIONS. CONCLUSION: BASED ON THE INFORMATION PROVIDED, FUNCTIONAL AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE CANNOT BE DEFINED. A MANUFACTURING ISSUE CANNOT BE PROVED OR DISPROVED. PLEASE NOTE THAT THE CANNULA WAS NOT RETURNED, NO INFORMATION HAVE BEEN PROVIDED ACCORDING TO THE PRESENCE OR ABSENCE OF SILICONE ON THE BALLOON BEFORE INSERTION AND THE IBT IS MEETING ALL THE SPECIFICATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE TO TREAT A T6 ACUTE COMPRESSION FRACTURE. BOTH THE BIOPSY DEVICE AND DRILL WERE USED PRIOR TO INSERTING THE IBT INTO THE VERTEBRAL BODY. REPORTEDLY, THE BALLOON ON THE IBT FAILED TO ADVANCE DOWN THE CANNULA AND BECAME LODGED BEFORE BEING INSERTED INTO THE VERTEBRAL BODY. IT WAS REPORTED THAT THE SURGEON THEN ATTEMPTED TO USE THE OTHER BALLOON IN THE KIT AND EXPERIENCED THE SAME PROBLEM. THE BIOPSY DEVICE AND DRILL WERE REINSERTED IN AN ATTEMPT TO CREATE A CLEAR CHANNEL FOR THE BALLOON. ONCE AGAIN, ACCORDING TO THE REPORT, "THE BALLOON WAS GETTING HUNG IN THE CANNULA AND ONCE IT FINALLY CLEARED THE CANNULA IT WOULDN'T PROGRESS TOWARD THE ANTERIOR WALL OF THE VERTEBRAL BODY". THE BIOPSY DEVICE AND DRILL WERE INSERTED AGAIN TO CLEAR A CHANNEL AND THE BALLOONS STILL WOULD NOT ADVANCE. A NEW KIT WAS OPENED AND THE IBTS FROM THIS KIT "WORKED PERFECTLY" ACCORDING TO THE REPORT. IT WAS REPORTED THAT THERE WAS A 10 MINUTE DELAY IN THE OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0006327678 (X2)

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE BIOPSY DEVICE, DRILL, CANNULA