BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVED SINUS BURS

    MDR report key: 4086273 · Received September 12, 2014

    Report

    Report Number
    3004209178-2014-16980
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1884016HR - BLADE, RAD 60, 4MM, M4 ROTAT 5/BX; MANUFACTURE DATE ¿ DECEMBER 21, 2011; LOT - H8080058; USE BEFORE DATE ¿ DECEMBER 21, 2015. (B)(4).

    Additional Manufacturer Narrative · 1

    1883672HS: TWO SAMPLES WERE RECEIVED. THE CONDITION OF THE DEVICES SHOWED CUSTOMER USE AS THERE WAS PRESENCE OF CONTAMINANTS ON THE SAMPLES. THE SPIRAL WRAP WAS FOUND BROKEN NEAR THE TIP OF BOTH SAMPLES. THE INNER SHAFT ASSEMBLY WITH SPIRAL WRAP COULD NOT BE RETRIEVED FROM THE OUTER SHAFT DUE TO THE CURVED DESIGN OF THE BUR. THE SPIRAL WRAP BREAKAGE NEAR THE TIP IS INDICATIVE OF POSSIBLE PROCEDURAL, ANATOMICAL, AND/OR OPERATIONAL FACTORS ENCOUNTERED BY THE CUSTOMER DURING THE PROCEDURE WHICH MAY HAVE LED TO THE FAILURE OBSERVED ON THE DEVICE. THESE FACTORS INCLUDE AND ARE NOT LIMITED TO DIFFICULT ANATOMICAL LOCATION, HARD BONE/TISSUE STRUCTURE. THESE FACTORS CAN CAUSE THE CUSTOMER TO EXERT PRESSURE, MANIPULATE AND/OR MANEUVER THE DEVICE IN A MANNER THAT MAY LEAD TO HYPEREXTENSION OF THE SPIRAL WRAP ASSEMBLY. THE BLUE HUB WAS OBSERVED AND THERE WERE NO DIMPLES TO INDICATE CUSTOMER MISLOADING OF DEVICE. THERE WERE NO INDICATIONS OF ANY MANUFACTURING DEFECT. UPON OBSERVING THE BUR HEAD, CONSIDERABLE AMOUNT OF BIO-RESIDUE WAS VISIBLE BUT NO OBVIOUS DAMAGE IN TERMS OF BUR HEAD FRAGMENTATION WAS FOUND. 1884016HR: THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE] AND THE DEVICE WAS RETURNED IN THE FINISHED GOOD PACKAGING. THE INNER AND OUTER SPIRAL WRAPS WERE STRETCHED AND BROKEN IN MULTIPLE LOCATIONS WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS NO DEFINITIVE EVIDENCE TO INDICATE A CAUSE. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A COMBINED FRONTAL DRILL OUT PROCEDURE, THE TIPS OF 4 BURRS BROKE OFF AND HAD TO BE RETRIEVED FROM THE PATIENT WITH A GIRAFFE. IN ADDITION, ONE RAD 60 BLADE CAME UNCOILED DURING USE IN THE SAME PROCEDURE. THE SALES REP STATED THAT THE DOCTORS ARE FAMILIAR WITH THE PRODUCTS AND SAY THEY DID NOT PUT TOO MUCH SIDE PRESSURE OR TORQUE ON THE BURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566017 CURVED SINUS BURS BUR, EAR, NOSE AND THROAT EQJ MDT PUERTO RICO OPERATIONS CO 1883672HS H7891087

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR