BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR

    MDR report key: 5091193 · Received September 21, 2015

    Report

    Report Number
    1045254-2015-00311
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 26, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES WERE RECEIVED FOR EVALUATION BUT ANALYSIS HAS NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM INITIAL REPORTER REPORTING ¿THE TIP BROKE DURING USE BUT WAS STILL ATTACHED TO THE DRILL WHEN PULLED OUT OF THE PATIENT.¿ NO FURTHER INFORMATION WAS PROVIDED. CONCOMITANT MEDICAL PRODUCTS: 1883672HS ¿ HIGH SPEED DIAMOND BUR, LOT # 0209855842 1884016HRE ¿ M4 ROTATABLE BLADE, RAD 60 4MM, LOT # 0209914694. THREE ATTACHMENTS WERE RETURNED FOR EVALUATION. EVALUATION RESULTS ARE AS FOLLOWS: PRODUCT 1 ANALYSIS - PRODUCT ANALYSIS FOUND THE CONDITION UPON RECEIPT: 1 UN-SEALED SAMPLE, PART NUMBER 1883672HS, FROM LOT NUMBER 0209935164 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 (ASSET 1080-J), SCALE. EVALUATION: WHEN COMPARED TO THE ASSEMBLY DRAWING: VISUALLY, THE TIP BROKE OFF WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PORTION THAT BECAME DETACHED MEASURED 0.515¿. THE INNER SHAFT WAS BENT AT THE PROXIMAL END, GOUGED 3/4¿ FROM THE INNER HUB, AND GOUGED JUST PROXIMAL TO THE HEAD IN THE SUPPORT AREA WHICH ARE ALL INDICATORS OF EXCESS PRESSURE BEING APPLIED DURING USE. THE DISTAL END OF THE OUTER TUBE WAS GOUGED AND FLARED WHICH IS CONSISTENT WITH EXCESS PRESSURE BEING APPLIED DURING USE. THE INSTRUCTIONS FOR USE WARNS THAT EXCESSIVE PRESSURE CAN CAUSE DAMAGE TO THE BUR / BLADE. IN CONCLUSION, THE COMPLAINT WAS CONFIRMED FOR THE ALLEGED MALFUNCTION [TIP BROKE OFF]. BASED ON THE AVAILABLE EVIDENCE AND INFORMATION THE MOST LIKELY UNDERLYING CAUSE IS CONSISTENT WITH, MISUSE / USER ERROR. PRODUCT 2 ANALYSIS - CONDITION UPON RECEIPT: 1 UN-SEALED SAMPLE, PART NUMBER 1883672HS, FROM LOT NUMBER 0209855842 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), IPC CONSOLE (PART EC300) IN CONJUNCTION WITH AN M4 HANDPIECE (PART 1898200T). EVALUATION: WHEN COMPARED TO THE ASSEMBLY DRAWING: VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE BUR LOADED AND LOCKED INTO THE HANDPIECE, RAN AT 12,000 RPM IN FORWARD DIRECTION, AND CUT SAW BONE WITH NO ISSUES. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING AND THEREFORE HAS BEEN RULED OUT AS A POTENTIAL CAUSE. IN CONCLUSION, THE COMPLAINT WAS NOT CONFIRMED FOR THE ALLEGED MALFUNCTION [WOULD NOT LOCK INTO HANDPIECE]. BASED ON THE AVAILABLE EVIDENCE AND INFORMATION THE UNDERLYING CAUSE IS NOT EVIDENT / UNCONFIRMED FAILURE. PRODUCT 3 ANALYSIS - CONDITION UPON RECEIPT: 1 UN-SEALED SAMPLE, PART NUMBER 1884016HRE, FROM LOT NUMBER 0209914694 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), IPC CONSOLE (PART EC300) IN CONJUNCTION WITH AN M4 HANDPIECE (PART 1898200T), CALIPERS (ASSET 1080-J). EVALUATION: WHEN COMPARED TO THE ASSEMBLY DRAWING: VISUALLY, THE MIDDLE ASSEMBLY [SPIRAL WRAP] WAS STRETCHED BY APPROXIMATELY 0.09¿. FUNCTIONALLY THE BLADE WOULD LOAD INTO A HANDPIECE AND RUN AT 5000RPM OSCILLATE MODE / DIRECTION WITH NO ISSUES. WITH THE MIDDLE ASSEMBLY STRETCHED, A MISMATCH OCCURRED BETWEEN THE INNER AND MIDDLE ASSEMBLIES AT THE CUTTING TIP WHICH WOULD HAVE RESULTED IN ELIMINATION OR REDUCED CUTTING PERFORMANCE AND WOULD HAVE RESULTED IN THE REPORTED EVENT. THERE WERE NO INDICATORS AS TO WHAT CAUSED THE OBSERVED DAMAGE AND A LACK OF EVIDENCE TO POINT TO AN INDIVIDUAL CAUSE. MANUFACTURING / PRODUCTION, MISUSE, MISHANDLING, AND OPERATIONAL CONTEXT CANNOT BE RULED OUT AS POTENTIAL CAUSES. IN CONCLUSION, THE COMPLAINT WAS CONFIRMED FOR THE ALLEGED MALFUNCTION [STOPPED OSCILLATING]. BASED ON THE AVAILABLE EVIDENCE AND INFORMATION THERE ARE MULTIPLE POTENTIAL CAUSES / CONFIRMED FAILURE AND EACH CAUSE IS LIKELY. (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 DURING A CASE, "THE BURR WOULD NOT LOCK INTO THE M4 [HANDPIECE], THE TIP OF ONE BURR BROKE OFF AND THE PIECE WAS RETRIEVED FROM THE PATIENT, ONE BLADE STOPPED OSCILLATING." THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM INITIAL REPORTER REPORTING 蔈E TIP BROKE DURING USE BUT WAS STILL ATTACHED TO THE DRILL WHEN PULLED OUT OF THE PATIENT.頎O FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623358 XPS® BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1883672HS 0209935164

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR