BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG

    MDR report key: 3943596 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13218
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS STATED, ¿THE CONDITION OF THE DEVICE SHOWED CUSTOMER USE AS THERE WAS PRESENCE OF CONTAMINANTS ON THE OUTER SHAFT ASSEMBLY¿FROM VISUAL EVALUATION, THE SPIRAL WRAP WAS FOUND HYPEREXTENDED AT THE MIDDLE AND BROKEN NEAR THE TIP. THE DISTAL TIP REMAINED INTACT AND DID NOT DETACH FROM THE BROKEN SPIRAL WRAP. THERE WERE NO SIGNS OF DEVICE MISLOADING BY CUSTOMER AS THERE WERE NO DIMPLES PRESENT ON THE BLUE HUB. THE SPIRAL WRAP HYPEREXTENSION AND BREAKAGE NEAR THE TIP IS INDICATIVE OF POSSIBLE PROCEDURAL / ANATOMICAL / OPERATIONAL FACTORS ENCOUNTERED BY THE CUSTOMER DURING PROCEDURE WHICH MAY HAVE LED TO THE FAILURE. 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 ITS BREAKAGE. THE BUR HEAD REMAINED INTACT ON THE BROKEN SPIRAL WRAP PIECE AND DID NOT SHOW ANY ANOMALIES.¿ METHOD: ACTUAL DEVICE EVALUATED; VISUAL INSPECTION; PHOTOGRAPHIC INSPECTION. RESULTS: STRESS PROBLEM. CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ANALYSIS HAS NOT YET BEEN COMPLETED. METHOD: NO TESTING METHODS PERFORMED. RESULTS: RESULTS PENDING COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLADE BROKE INTER-OPERATIVELY DURING FRONTAL SINUS CASE, NO FRAGMENTS, NO DELAY IN CASE, DOCTOR GRABBED ANOTHER BUR. NO ADDITIONAL INTERVENTION WAS REQUIRED. SHAFT BROKE OFF NEAR TIP WHILE IN SURGICAL FIELD. THIS IS A HIGH-SPEED BUR, AND BREAKS OF HIGH SPEED BURS IN THE PAST HAVE RESULTED IN HEATING UP TO TEMPERATURES HIGH ENOUGH TO CAUSE BURNS. THIS REPORT CONTAINED NO MENTION OF HEATING UP, AND THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422870 BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG BUR, EAR, NOSE AND THROAT EQJ MDT PUERTO RICO OPERATIONS CO 1883672HS HG01AWZ

    Patients

    Seq Age Sex Outcome Treatment
    1