BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - STYLUS TRANSNASAL

    MDR report key: 4782353 · Received May 19, 2015

    Report

    Report Number
    1045254-2015-00173
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Report Date
    April 1, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K081277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: TN39MFL, TRANSNASAL 3MM BUR MATCH FLUTED; LOT ¿ 0209179104; MANUFACTURED DATE ¿ JANUARY 23, 2015; USE BEFORE DATE ¿ JULY 16, 2016; 510K - K081277 (B)(4). LOT 0209179104: THE SHAFT WAS TURNED BY HAND USING THE HEAD OF THE BUR WHILE VIEWING THE DRIVE MECHANISM [THE BUR TANG]; THE TANG WAS NOT TURNING WHICH INDICATED A BROKEN SHAFT AND WOULD RESULT IN THE REPORTED EVENT. THE HUB WAS BROKEN APART, AND THE SHAFT WAS REMOVED FROM THE ASSEMBLY FOR FURTHER ANALYSIS [IT MEASURED APPROXIMATELY 5.63¿ FROM TIP TO BREAK POINT]. THERE WAS A BREAK POINT AT THE PROXIMAL END WHICH CORRESPONDS TO THE DISTAL SIDE OF THE TACK WELD AND SECURES THE SHAFT TO THE TANG. WHEN VIEWED UNDER MAGNIFICATION, THE BREAK POINT OF THE SHAFT AT THE TANG SHOWED SIGNS OF HEAT DISCOLORATION WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE, HOWEVER THIS CANNOT BE CONFIRMED. THE SHAPE OF THE SHAFT BREAK IS CONSISTENT WITH SHEAR [OR LATERAL] STRESS. THE INFORMATION INDICATES THAT THE SHAFT BROKE AS A RESULT OF EXCESS PRESSURE/STRESS DURING USE OR AT SOME POINT DURING THE MANUFACTURING PROCESS. THE AMOUNT THAT EACH UNDERLYING CAUSE CONTRIBUTED TO THE REPORTED COMPLAINT CANNOT BE DETERMINED. LOT 0208987450, SAMPLE A: THE TIP OF THE BUR WAS MISSING FROM THE DEVICE, WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PORTION THAT BECAME DETACHED WAS NOT INCLUDED IN THE PACKAGE. WHEN VIEWED UNDER MAGNIFICATION, THERE WERE CIRCULAR PATTERNS AND WEAR MARKS AT THE SHAFT BREAK POINT WHICH INDICATES A FAILURE DUE TO TORSIONAL LOADS. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING WHICH HAS BEEN RULED OUT AS A LIKELY CAUSE. LOT 0208987450, SAMPLE B: THE SHAFT WAS TURNED BY HAND USING THE HEAD OF THE BUR WHILE VIEWING THE DRIVE MECHANISM [THE BUR TANG]; THE TANG WAS NOT TURNING WHICH INDICATED A BROKEN SHAFT AND WOULD RESULT IN THE REPORTED EVENT. THE HUB WAS BROKE APART AND THE SHAFT WAS REMOVED FROM THE ASSEMBLY FOR FURTHER ANALYSIS. THERE WAS A BREAK POINT AT THE PROXIMAL END WHICH CORRESPONDS TO THE DISTAL SIDE OF THE TACK WELD AND SECURES THE SHAFT TO THE TANG. WHEN VIEWED UNDER MAGNIFICATION, THE BREAK POINT OF THE SHAFT AT THE TANG SHOWED SIGNS OF HEAT DISCOLORATION WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE, HOWEVER THIS CANNOT BE CONFIRMED. THE SHAPE OF THE SHAFT BREAK IS CONSISTENT WITH SHEAR [OR LATERAL] STRESS. THE INFORMATION INDICATES THAT THE SHAFT BROKE AS A RESULT OF EXCESSIVE UNEVEN FORCE, WHICH MAY HAVE OCCURRED DURING LOADING OF THE BUR INTO THE HANDPIECE, ACTIVATION, OR PRODUCTION. FOR SAMPLE A, IT APPEARS THE TIP WAS BROKEN OFF DURING USE WHICH WOULD HAVE REQUIRED A RELATIVELY GREAT AMOUNT OF TORSION. FOR SAMPLE B, THE SHAFT BREAK MAY BE A RESULT MANY POSSIBLE PROCESSES. BASED ON THE ABOVE OBSERVATIONS; THE MOST LIKELY UNDERLYING CAUSE IS CONSISTENT WITH, [A} MISUSE/USER ERROR AND [B] MULTIPLE POTENTIAL CAUSES/CONFIRMED FAILURE. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING, PRIOR TO USE, THE BUR CAME OUT OF THE HOUSING. THE CUSTOMER INDICATED THAT THIS HAPPENED WITH TWO BURS ON THE SAME DATE IN THE SAME CASE. HOWEVER, THREE BURS WERE RETURNED FOR ANALYSIS. THERE WAS NO INJURY TO THE PATIENT, NO BREAKAGE OR FRAGMENTS DURING USE ON OR IN THE PATIENT. HOWEVER, THE PRODUCT ANALYSIS INDICATES THAT THE BUR TIP WAS MISSING FROM ONE OF THE RETURNED BURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327213 XPS® BUR - STYLUS TRANSNASAL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. TN30MFL 0208987450

    Patients

    Seq Age Sex Outcome Treatment
    1