BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHATEC TARGETING NEEDLE, TROCAR TIP (STAINLESS STEEL)

    MDR report key: 3857137 · Received June 9, 2014

    Report

    Report Number
    2027467-2014-00011
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 11, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT EVALUATION POSSIBLE. THE SUSPECT DEVICE HAS BEEN DISCARDED BY THE USER FACILITY. THE PROVIDED INSTRUCTION FOR USE (IFU) INS-073 STATE; THE TARGETING NEEDLE IS AN ETHYLENE OXIDE STERILIZED, SINGLE USE INSTRUMENT INTENDED TO FACILITATE ACCESS INTO THE VERTEBRAL BODY. WARNINGS: BREAKAGE OF THE DEVICE MAY REQUIRE SURGICAL INTERVENTION OR RETRIEVAL. THIS TARGETING NEEDLE SHOULD ONLY BE USED BY TRAINED PHYSICIANS. DURING PLACEMENT OF THE TARGETING NEEDLE, IT IS RECOMMENDED TO FREQUENTLY USE ALTERNATE IMAGING PLANES. IDEALLY, AN A-P, LATERAL, AND OBLIQUE VIEW SHOULD BE TAKEN AT ALL CRITICAL STEPS DURING THE PROCEDURE TO ENSURE PROPER POSITIONING AND ALIGNMENT, AND TO PREVENT KINKING OR BREAKAGE OF THE DEVICE. THIS PRODUCT IS A SINGLE USE DEVICE. DO NOT REUSE. RECONDITIONING, REFURBISHING, REPAIR, MODIFICATION, OR RESTERILIZATION OF THE DEVICE TO ENABLE FURTHER USE IS EXPRESSLY PROHIBITED. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER (B)(6) REPORTED THAT THE BLUE HANDLE OF A TARGETING NEEDLE SEPARATED/BROKE AWAY FROM THE TROCAR SHAFT. THE CASE WAS EXTENDED APPROXIMATELY 1.5 HOURS IN ORDER TO REMOVE THE IMPACTED INSTRUMENT. ADDITIONAL INFORMATION INDICATED THAT THE TARGETING NEEDLE WAS INSERTED UNDER NORMAL TRAJECTORY. UPON CORRECTIONAL MANEUVERS THE DEVICE APPEARS TO BECOME SLIGHTLY CURVED. AT THE BEGINNING OF THE PEDICLE, THE SURGEON ENCOUNTERED EXTREMELY SCLEROTIC BONE. HE UTILIZED A HAMMER TO VIGOROUSLY BEAT THE CAP OF THE STYLUS TO POSITION THE TARGETING NEEDLE JUST PAST THE REAR WALL OF THE VERTEBRA. WHILE ATTEMPTING TO REMOVE THE TROCAR FROM THE CANNULATED SHAFT OF THE NEEDLE, THE BLUE STYLUS CAP SEPARATED FROM THE TROCAR. VARIOUS METHODS/ATTEMPTS TO REMOVE THE TROCAR ALSO RESULTED IN THE SEPARATION OF THE CANNULATED SHAFT HANDLE. THE ENTIRE DEVICE WAS EVENTUALLY REMOVED FROM THE PATIENT VIA A DRILL CORER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333815 ALPHATEC TARGETING NEEDLE, TROCAR TIP (STAINLESS STEEL) LXH LXH ALPHATEC SPINE INC 79701 34914

    Patients

    Seq Age Sex Outcome Treatment
    1 Other