BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICUT® STRAIGHT SHAFT 4MM 11CM LONG

    MDR report key: 7072546 · Received November 30, 2017

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    Report

    Report Number
    3004209178-2017-24644
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 3, 2017
    Report Date
    April 16, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EQJ
    UDI-DI
    20681490047450
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS ARE NOT AVAILABLE. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS FROM THE INTERNATIONAL FACILITY; NOT YET RECEIVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS INDICATES THAT ONE OPENED SAMPLE OF PART NUMBER 1884004 FROM LOT NUMBER HG1T3QZ WAS RECEIVED. THIS LOT WAS MANUFACTURED APRIL 20, 2017. A MICROSCOPE AND CALIPERS WERE USED TO EVALUATE THE DEVICE. VISUALLY, THE DISTAL TIP HAD BROKEN OFF THE INNER CUTTER WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PORTION THAT BECAME DETACHED MEASURED APPROXIMATELY 0.24¿ IN LENGTH. THE BREAK OCCURRED AT THE FIRST PROXIMAL TOOTH VALLEY. THE OUTER ASSEMBLY TEETH WERE DEFORMED IN SUCH A WAY THAT INDICATES THE INNER BLADE TEETH IMPACTED THE OUTER TEETH IN A CLOCKWISE MOTION AT THE 3RD PROXIMAL VALLEY WHICH RESULTED IN THE OBSERVED BREAK. THERE WAS NO ALLEGATION OF A DEFECT PRIOR TO USE. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS DAMAGE TO THE HUBS THAT IS CONSISTENT WITH IMPROPER LOADING: DIMPLES ON THE FRONT HUB PRIOR TO THE LOCKING AREA CAUSED BY THE HANDPIECE LOCKING MECHANISM; LOCKING AREA DEFORMATION CAUSED BY THE BACK SIDE OF THE FRONT COLLET OF THE HANDPIECE; AND DEFORMATION OF THE INNER HUB CHEVRONS CAUSED BY THE HANDPIECE DRIVE MECHANISM. THERE WAS EVEN WEAR ON THE INNER 5/8¿ FROM THE DISTAL FACE OF THE INNER HUB. THERE WAS UNEVEN WEAR AT THE CUTTING TIP WHICH MAY INDICATE AN INTERFERENCE FIT BETWEEN THE INNER AND OUTER ASSEMBLIES AT THE TIP. THERE WAS AN OUT OF SPECIFICATION CONDITION IDENTIFIED AS IT RELATES TO THE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE TIP OF INNER BLADE WAS BROKEN DURING THE PROCEDURE. THE TIP OF INNER BLADE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT IMPACT. A NEW PACK OF BLADE WAS OPENED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851408 TRICUT® STRAIGHT SHAFT 4MM 11CM LONG BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC PUERTO RICO OPERATIONS CO. 1884004 HG1T3QZ 20681490047450

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR