BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG

    MDR report key: 2633371 · Received June 28, 2012

    Report

    Report Number
    1045254-2012-00366
    Event Type
    Injury
    Date Received
    June 28, 2012
    Date of Event
    May 31, 2012
    Report Date
    June 1, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS USED FOR TREATMENT PURPOSES. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND DEVICE EVALUATION IS CURRENTLY UNDERWAY. PRODUCT DESCRIPTION: THE STRAIGHTSHOT MICRODEBRIDER SYSTEM IS DESIGNED TO ACCOMMODATE A NUMBER OF OTORHINOLARYNGOLOGY PROCEDURES, INCLUDING FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), ADENOIDECTOMY, REMOVAL OF LARYNGEAL AND VOCAL CORD LESIONS, RHINOPLASTY, DERMABRASION, AND SUBMENTAL LIPECTOMY. A VARIETY OF DISPOSABLE BLADES AND BURS ARE AVAILABLE FOR THIS PURPOSE. THESE DISPOSABLES ARE FOR USE WITH ALL STRAIGHTSHOT AND ALL MAGNUM MICRODEBRIDER HANDPIECES. WARNINGS INCLUDE, BUT ARE NOT LIMITED TO EXCESSIVE PRESSURE APPLIED TO BUR MAY CAUSE BUR FRACTURE. SHOULD A BUR FRACTURE OCCUR DURING USE EXTREME CARE MUST BE EXERCISED TO ENSURE THAT ALL FRAGMENTS OF THE BUR ARE RETRIEVED AND REMOVED FROM THE PATIENT. UNREMOVED BUR FRAGMENTS MAY CAUSE TISSUE DAMAGE TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(6) 2020. ONE BUR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION BY A QUALITY ENGINEER. THE ANALYSIS FOUND ONE BUR WAS RECEIVED WITH THE ORIGINAL INNER-POUCH AND INNER POUCH LABEL ENCLOSED IN A ZIP-LOCK BAG. THE INNER POUCH LABEL IDENTIFIED THE BUR AS ITEM # (B)(4); HIGH SPEED TAPERED DIAMOND BUR FROM LOT #0205683986. THE BUR WAS HYPER-EXTENDED FROM THE INNER SHAFT BUT WAS STILL ATTACHED TO THE END OF THE UNWOUND SPIRAL. THE INNER SPIRAL WRAP WAS SHEARED AND COMPLETELY SEPARATED FROM THE BUR END. THE BUR REMAINED ATTACHED TO THE OUTER-SPIRAL WRAP. THE BUR WAS USED BASED ON THE FOLLOWING OBSERVATIONS USING A 20X MAGNIFICATION MICROSCOPE: - MANY OF CUTTING FACETS ON THE BUR WERE DULLED AND CHIPPED. - FOREIGN MATERIAL WHICH APPEARED TO BE BONE MATTER WAS EMBEDDED BETWEEN THE FACETS. - FOREIGN MATERIAL WHICH APPEARED TO BE BLOOD WAS PRESENT ON THE SURFACE OF THE SPIRALS. IN CONCLUSION, THE CONDITION OF THE BUR DEMONSTRATES SEVERE USE OF THE BUR. THIS, IN CONJUNCTION WITH THE EXTENSION AND ULTIMATE BREAKAGE OF THE SPIRAL WRAP INDICATES THE ROOT CAUSE IS MOSTLY LIKELY FROM EXCESSIVE USE OF THE BUR.

    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 THE TIP OF THE BUR WAS BROKEN DURING AN ENDOSCOPIC SINUS SURGERY. BROKEN FRAGMENTS WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 1883672HS 0205683986

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention