BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 5267426 · Received December 4, 2015

    Report

    Report Number
    1045254-2015-00410
    Event Type
    Malfunction
    Date Received
    December 4, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 11, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MANUFACTURER: 01/11/2016. THE DEVICE WAS RECEIVED FOR PRODUCT ANALYSIS. CONDITION UPON RECEIPT: 1 UN-SEALED SAMPLE, PART NUMBER 1884005, FROM LOT NUMBER 0 209773942 RECEIVED; THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. EQUIPMENT USED: MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0, 65 TO 5, 0 MAGNIFICATION SETTINGS), CALIPERS. EVALUATION: WHEN COMPARED TO THE ASSEMBLY DRAWING, VISUALLY THE TIP OF THE INNER BLADE WAS BROKE OFF WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE TIP WAS RETURNED AND MEASURED 0.22¿ LONG. THE BREAK POINT CORRESPONDS TO THE FIRST PROXIMAL VALLEY OF THE INNER BLADE TOOTH. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS DAMAGE TO THE HUBS THAT IS CONSISTENT WITH IMPROPER LOADING - DIMPLES ON THE FRONT HUB PRIOR TO THE LOCKING AREA CAUSED BY THE HANDPIECE LOCKING MECHANISM; LOCKING AREA DAMAGE CAUSED BY THE BACK SIDE OF THE FRONT COLLET OF THE HANDPIECE; AND DAMAGE TO THE INNER HUB CHEVRONS CAUSED BY THE HANDPIECE DRIVE MECHANISM. THE INSTRUCTIONS FOR USE HAS DETAILED INSTRUCTIONS FOR PROPERLY LOADING A BUR/BLADE INTO THE HANDPIECE. THE IMPROPERLY LOADED BLADE MAY HAVE CONTRIBUTED TO THE MALFUNCTION. THE DEFORMATION OF THE BREAK IS CONSISTENT WITH THE INNER TIP CONTACTING THE OUTER TIP DURING USE. FOR THIS BREAK TO OCCUR, THE TIP WOULD HAVE TO BE DEFORMED OR BECOME DEFORMED AND / OR COME IN CONTACT WITH AN UNAPPROVED MATERIAL. THE MOST PROBABLE CAUSE OF THE EVENT IS RELATED TO OPERATIONAL CONTEXT. METHOD ¿ ACTUAL DEVICE EVALUATED; LABELING EVALUATION; MICROSCOPIC INSPECTION. RESULTS ¿ DEFORMATION PROBLEM; FRACTURE PROBLEM. CONCLUSION ¿ OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION.

    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 DURING AN ENDOSCOPIC SINUS SURGERY,WHILE USING THE SILVER BULLET BLADE, IT BROKE OFF MID USE INSIDE THE PATIENT. FOLLOW-UP WITH THE CUSTOMER REPORTED THE DOCTOR NOTICED THE TIP OF THE BLADE BROKE OFF MID-USE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799322 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884005 0209773942

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR