BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 5765590 · Received July 1, 2016

    Report

    Report Number
    1045254-2016-00216
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 7, 2016
    Report Date
    June 8, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY MEDTRONIC (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    DATE MANUFACTURER RECEIVED: JULY 27, 2016. THE PRODUCT ANALYSIS INDICATES THAT ONE UN-SEALED SAMPLE OF PART NUMBER 1882900 FROM LOT NUMBER 62818000 WAS RECEIVED. THE EQUIPMENT USED FOR EVALUATION INCLUDE A MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0, 65 TO 5, 0 MAGNIFICATION SETTINGS) AND CALIPERS. WHEN COMPARED TO THE ASSEMBLY DRAWING, 0.695¿ OF THE DISTAL CUTTING TIP BROKE OFF, WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE BREAK POINT CORRESPONDS TO THE DISTAL END OF THE LOCKING COLLAR, WHICH LIKELY INDICATES FAILURE UNDER SHEAR OR BENDING LOAD. THIS DEVICE WAS MANUFACTURED JUNE 20, 2009 AND DELIVERED TO THIS CUSTOMER ON OCTOBER 1, 2009. ALTHOUGH THE CUSTOMER INDICATED THE BUR BROKE DURING TESTING / SEATING, AND BEFORE ACTUAL USE, THE ITEM WAS RETURNED IN A STERILIZATION BAG AND HAD WEAR MARKS ON THE SHAFT INDICATING USE (LIKELY FROM PREVIOUS USE(S)). THE DRILL IS REUSABLE HOWEVER THE LIFE OF THE DEVICE IS CONTINGENT UPON MANY FACTORS INCLUDING EXTENT OF USAGE AND HANDLING. METHOD: ACTUAL DEVICE EVALUATED. (B)(4). CONCLUSION: USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    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 THE TIP OF THE DEVICE BROKE OFF. THE SURGICAL TEAM WAS TESTING THE SEATING (ATTACHMENT) OF THE BUR IN THE DRILL PRIOR TO USE AND THE TIP OF THE BUR BROKE OFF. THE FRAGMENT WAS NOWHERE NEAR THE PATIENT NOR HAD PATIENT CONTACT. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419442 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1882900 62818000

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR