BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED SINUS BURS

    MDR report key: 3844097 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09993
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: THE FOLLOWING PRODUCTS WERE MANUFACTURED AT: (B)(4)¿ 70DEG HI SPEED DIAMOND BUR (1883672HS); QTY: 2; LOT: HG02VJH; MANUFACTURED: MARCH 28, 2014; USE BY: MARCH 28, 2022; 510K: EXEMPT THE FOLLOWING PRODUCTS WERE MANUFACTURED AT: MEDTRONIC XOMED, INC. (B)(4) ¿ 4.3MM X 13CM M4 QUADCUT BLADE (1884380EM); QTY: 1; LOT: 0207877678; MANUFACTURED: JANUARY 03, 2014; USE BY: JANUARY 03, 2016; 510K: K130608 ¿ 4MMX13CM M4 ROTATABLE TRICUT BLADE (1884080EM); QTY: 1; LOT: 0208166969; MANUFACTURED: MARCH 22, 2014; USE BY: MARCH 11, 2016; 510K: EXEMPT ¿ 4MMX13CM M4 ROTATABLE TRICUT BLADE (1884080EM); QTY: 1; LOT: 0208198233; MANUFACTURED: MARCH 31, 2014; USE BY: MARCH 20, 2016; 510K: EXEMPT ¿ 4MMX13CM M4 ROTATABLE TRICUT BLADE (1884080EM); QTY: 1; LOT: 0208198234; MANUFACTURED: MARCH 31, 2014; USE BY: MARCH 20, 2016; 510K: EXEMPT. (B)(4). THE DEVICE WAS RETURNED, EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. METHOD: NO TESTING METHODS PERFORMED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, A TOTAL OF 7 DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION PURPOSES (DETAILED AS FOLLOWS): THE CONDITION OF ALL THE SAMPLES SHOWED EVIDENCE OF CUSTOMER USE BASED ON THE PRESENCE OF A CONSIDERABLE AMOUNT OF BIO-RESIDUE. HIGH SPEED BURS (QUANTITY 3) - THE SPIRAL WRAP ASSEMBLY ON ONE BUR WAS FOUND HYPEREXTENDED AND BROKEN NEAR THE TIP. ON THE OTHER TWO BURS, THE SPIRAL WRAP ASSEMBLY WAS ALSO FOUND HYPEREXTENDED WITH SEVERE HYPEREXTENSION ON ONE BUR THAN THE OTHER¿BUT THE DISTAL TIP REMAINED INTACT AND DID NOT DETACH FROM THE SPIRAL WRAP ASSEMBLY ON BOTH BURS. THERE WAS NO INDICATION OF CUSTOMER MISLOADING OF DEVICE SINCE NO DIMPLES WERE FOUND ON THE HUBS ON ALL THREE BURS. THERE WERE NO INDICATIONS OF CUSTOMER MISUSE OR MANUFACTURING DEFECTS. QUADCUT AND TRICUT BLADES (QUANTITY 4) - ALL BLADES WERE FOUND TO HAVE THE INNER SHAFT BROKEN CLOSE TO THE PROXIMAL END OF THE HUB ASSEMBLY. ONLY THREE BROKEN HUBS WERE RETURNED FOR EVALUATION AND THE THIRD BROKEN HUB ASSEMBLY WAS NOT RETURNED FOR EVALUATION. THE INNER SHAFT ON ALL THREE ASSEMBLIES WAS FOUND BROKEN AT APPROXIMATELY AT THE SAME LOCATION. THE INNER SHAFT ASSEMBLIES ON ALL FOUR SAMPLES COULD NOT BE RETRIEVED DUE TO CONSIDERABLE AMOUNT OF RESISTANCE OBSERVED. THE BREAKAGE POINTS ON ALL THREE INNER SHAFTS WERE OBSERVED AND EXHIBITED CIRCULAR MARKINGS ON THE BROKEN HUBS, INCLUDING AT THE BREAKAGE POINTS WHICH MAY BE INDICATIVE OF AGGRESSIVE USE OF THE DEVICE. THERE WAS NO EVIDENCE OF MANUFACTURING DEFECTS, HOWEVER THE INNER HUB HAD A MINOR CRACK WHICH MAY POSSIBLY BE RELATED TO INCORRECT LOADING OF THE DEVICE. (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

    IT WAS REPORTED THAT 3 ¿ 70 DEGREES HIGH SPEED DIAMOND BURS, 3 ¿ 4MMX13CM M4 ROTATABLE TRICUT BLADES AND 1 - 4.3MMX13CM M4 QUADCUT BLADE BROKE INTRAOPERATIVELY. ALL DEVICES BROKE UNDER HIGH STRESS CONDITIONS WHERE EXCESSIVE FORCE WAS BEING APPLIED TO THEM AND THEY WERE BEING USED AGAINST INTENDED USE TO TAKE DOWN BONE IN A FRONTAL RECESS SURGERY ON A (B)(6) YEAR OLD MALE, WEIGHING (B)(6). ALTHOUGH THERE WAS NO PATIENT IMPACT OR INJURY REPORTED AS A RESULT OF THIS EVENT¿ONE OF THE 70 DEGREES HIGH SPEED DIAMOND BURS THAT BROKE, RESULTED IN A FRAGMENT FALLING INTO THE PATIENT WHICH WAS SUCCESSFULLY RETRIEVED WITHOUT ANY ADDITIONAL PROCEDURES OR EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321965 CURVED SINUS BURS BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC PUERTO RICO OPERATIONS CO. 1883672HS HG02VJH

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR