BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG

    MDR report key: 3995270 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14965
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED FOR EVALUATION ON (B)(4) 2014. DEVICES EVALUATED TOGETHER ON (B)(4) 2014. THE PRODUCT ANALYSIS INDICATED THAT THE ENGINEERING TEAM RECEIVED (B)(4) SAMPLES WITH ORIGINAL OPENED POUCHES AND LABELS. SOME OF THE SAMPLES WERE IN MULTIPLE PIECES SO IT WAS NOT POSSIBLE TO REASSEMBLE ALL OF THE SAMPLES. THE CONDITION OF ALL DEVICES SHOWED CUSTOMER USE AS THERE WAS PRESENCE OF CONTAMINANTS ON THE BUR HEAD FOR ALL SAMPLES. FROM VISUAL EVALUATION, THE SPIRAL WRAP WAS FOUND HYPEREXTENDED OR BROKEN IN ALL SAMPLES. THE SPIRAL WRAP HYPEREXTENSION, UNRAVELING, OR BREAKING IS INDICATIVE OF POSSIBLE PROCEDURAL / ANATOMICAL / OPERATIONAL FACTORS ENCOUNTERED BY THE CUSTOMER DURING PROCEDURE WHICH MAY HAVE LED TO THE FAILURE OBSERVED ON THE DEVICE. THESE FACTORS INCLUDE AND ARE NOT LIMITED TO DIFFICULT ANATOMICAL LOCATION, HARD BONE/TISSUE STRUCTURE. THESE FACTORS CAN CAUSE THE CUSTOMER TO EXERT PRESSURE, MANIPULATE AND/OR MANEUVER THE DEVICE IN A MANNER THAT MAY LEAD TO HYPEREXTENSION OR BREAKAGE OF THE SPIRAL WRAP ASSEMBLY. THE BUR HEADS WERE FOUND TO HAVE CONSIDERABLE AMOUNT OF BIO-RESIDUE BUT DID NOT APPEAR TO HAVE BEEN DAMAGED IN ANY MANNER. METHOD: ACTUAL DEVICE EVALUATED; VISUAL INSPECTION; RESULTS: STRESS PROBLEM. CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: BUR 1883070HS 3PK FRONTAL FINESSE HI SPE, 510K: EXEMPT EQJ, LOT# 0206557832, MANUFACTURE DATE: 2013-01-15, USE BEFORE: 2021-01-13 BUR 1883673HS 3PK CHOANAL ATRESIA TAPER, 510K: EXEMPT EQJ, LOT# 0208088399, MANUFACTURE DATE: 2014-02-27, USE BEFORE 2022-02-25. (B)(4). THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. (B)(4). THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER SENT REPORT TO FDA, A MEDWATCH (# (B)(4)) WAS RECEIVED ON (B)(4) 2014. IT WAS REPORTED THAT ¿DURING ENDO SINUS DRILLING, NINE DRILLS BROKE: FIVE OF THE HIGH SPEED TAPERED DIAMOND BURR 4 MM 70 DEGREE (REF#(B)(4)). TWO OF THE HIGH SPEED RAD FRONTAL FINESSE BURR 3MM 40 DEGREE (REF#(B)(4)). TWO OF THE HIGH SPEED TAPERED DIAMOND CHOANAL 4MM 15 DEGREE (REF#(B)(4)). ADDITIONAL DEVICES WERE OBTAINED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.¿ THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468500 BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG BUR, EAR, NOSE AND THROAT EQJ MDT PUERTO RICO OPERATIONS CO 1883672HS H9051493

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR