BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - HIGH SPEED RAD®

    MDR report key: 6059437 · Received October 26, 2016

    Report

    Report Number
    1045254-2016-00367
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 20, 2016
    Report Date
    August 19, 2019
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (1) RAD55 HI SPEED 3.6 CVD BUR 3PK (1883670HS); LOT: 0209834970; DATE OF MANUFACTURE: JULY 9, 2015; USE BY DATE: JULY 7, 2023; 510K: EXEMPT (2) 15CM X 4MM 15DEG CUTTING BUR (1884075HSE); LOT: 0208405153; DATE OF MANUFACTURE: JUNE 2, 2014; USE BY DATE: JUNE 1, 2018; 510K: EXEMPT (3) 15CM X 4MM 15DEG CUTTING BUR (1884075HSE); LOT: 0208054102; DATE OF MANUFACTURE: FEBRUARY 18, 2014; USE BY DATE: FEBRUARY 17, 2018; 510K: EXEMPT. IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, NO DEVICES WERE RECEIVED FOR EVALUATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT: 1883670HS, LOT NUMBER: 0209944308 - ANALYSIS FOUND THAT VISUALLY, THERE WAS BIOLOGICAL CONTAMINANTS COMPACTED IN THE FLUTES OF THE CUTTING TIP WHICH LIKELY REQUIRED THE USER TO APPLY EXCESS PRESSURE TO MAINTAIN PERFORMANCE. THERE WERE ALSO BIOLOGICAL CONTAMINANTS COMPACTED IN THE SUCTION AND IRRIGATION PORTS. THE DISTAL END OF THE SHAFT JUST PROXIMAL TO THE CUTTING TIP WAS ROUGH AND WORN WHICH IS AN INDICATION OF AGGRESSIVE USE. THERE WAS CORRESPONDING DAMAGE TO THE DISTAL END INSIDE DIAMETER OF THE OUTER TUBE. PRODUCT: 1883670HS, LOT NUMBER: 0209834970 - ANALYSIS FOUND THAT VISUALLY, THERE WAS BIOLOGICAL CONTAMINANTS COMPACTED IN THE FLUTES OF THE CUTTING TIP WHICH LIKELY REQUIRED THE USER TO APPLY EXCESS PRESSURE TO MAINTAIN PERFORMANCE. THE DISTAL END OF THE SHAFT JUST PROXIMAL TO THE CUTTING TIP WAS ROUGH AND WORN WHICH IS AN INDICATION OF AGGRESSIVE USE. THERE WAS CORRESPONDING DAMAGE TO THE DISTAL END INSIDE DIAMETER OF THE OUTER TUBE. THE SPIRAL WRAP WAS STRETCHED WHICH WAS LIKELY THE RESULT OF TORSIONAL LOAD DURING AGGRESSIVE USE. PRODUCT: 1884075HSE, LOT NUMBER: 0208054102 - ANALYSIS FOUND THAT WHEN VIEWED UNDER MAGNIFICATION, THERE WAS DAMAGE TO THE HUBS THAT IS CONSISTENT WITH IMPROPER OR DIFFICULTY LOADING THE DEVICE INTO THE HANDPIECE: DIMPLES ON THE FRONT HUBS PRIOR TO THE LOCKING AREA CAUSED BY A MISALIGNMENT OF THE HANDPIECE LOCKING MECHANISM; LOCKING AREA DEFORMATION CAUSED BY THE BACK SIDE OF THE FRONT COLLET OF THE HANDPIECE; AND DEFORMATION OF THE PROXIMAL INNER HUB CHEVRONS CAUSED BY THE HANDPIECE DRIVE MECHANISM. THE USER¿S GUIDE HAS DETAILED INSTRUCTIONS FOR PROPERLY LOADING A BUR/BLADE INTO THE HANDPIECE. ONE OF THE TWO SAMPLES HAD A DISLODGED HUB BUSHING HOWEVER THIS WAS LIKELY THE RESULT OF THE DEFORMED HUB. EVEN WITH THE DEFORMATION OF THE HUBS, FUNCTIONALLY, THE DEVICES LOADED SECURELY INTO A HANDPIECE. A BUR OR BLADE THAT IS NOT PROPERLY LOADED WOULD RESULT IN IMPROPER SUPPORT FROM THE HANDPIECE, ENGAGEMENT WITH THE SUCTION SEAL, DRIVE, AND LOCKING MECHANISM. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS. THE 1884004 - BLADE 1884004 TRICUT 5PK 4 MM (LISTED IN INITIAL MDR AS 1884075HSE - 15 CM X 4 MM 15 DEG CUTTING BUR; LOT - 0208405153); LOT - UNKNOWN; DATE OF MANUFACTURE ¿ UNKNOWN; USE BY DATE ¿ UNKNOWN; 510K ¿ EXEMPT; (B)(4). ONE OF FOUR BLADES/BURS WAS RETURNED. 1884004 (FORMERLY 1884075HSE FROM LOT 0208405153): THE PRODUCT ANALYSIS INDICATES THAT ONE OPENED SAMPLE OF PART NUMBER 1884004, FROM AN UNKNOWN LOT NUMBER WAS RECEIVED. THERE WAS A RESIDUE CONSISTENT WITH BIOLOGICAL CONTAMINANTS ON THE DEVICE. ALTHOUGH THE CUSTOMER REPORTED THE COMPLAINT DEVICE WAS PART 1884075HSE FROM LOT 0208405153, THE CONFIGURATION OF THE DEVICE INDICATED THE PART NUMBER WAS A 1884004. THE INNER SHAFT BROKE 0.59¿ FROM THE DISTAL FACE OF THE INNER HUB, WHICH WOULD HAVE RESULTED IN THE REPORTED MALFUNCTION. THE BREAK POINT CORRESPONDS TO THE PROXIMAL END OF THE OUTER TUBE IN THE FRONT HUB. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS DEFORMATION OF THE LOCKING AREA ON THE FRONT HUB AND STRIATIONS AROUND THE OUTSIDE DIAMETER OF THE BREAK POINT INDICATING METAL ON METAL CONTACT. A REVIEW OF THE SPECIFICATIONS DID NOT INDICATE ANY EVIDENCE TO POINT TO IMPROPER MANUFACTURING AND THERE WAS NO ALLEGATION OF A DEFECT PRIOR TO USE. THE INFORMATION INDICATES EXCESS PRESSURE WAS APPLIED DURING USE, WHICH CAUSED THE DEFORMATION OF THE LOCKING AREA; WHICH THEN CAUSED THE INNER SHAFT AND OUTER TUBE TO RUB TOGETHER UNTIL THE INNER SHAFT BROKE. THERE WAS NO INDICATION OF DEVICE FRAGMENTS AND THE BREAKAGE WOULD HAVE BEEN CONTAINED BY THE OUTER TUBE AND THE HANDPIECE. THE IFU WARNS THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 TWO RAD55 HI SPEED 3.6 CVD BURS AND TWO 15CM X 4MM 15DEG CUTTING BURS ¿BROKE VERY FAST¿ INTRAOPERATIVELY. THIS IS THE ONLY INFORMATION PROVIDED AND THERE WAS ALSO NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708910 XPS® BUR - HIGH SPEED RAD® BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1883670HS 0209944308

    Patients

    Seq Age Sex Outcome Treatment
    1