BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG

    MDR report key: 2477065 · Received March 5, 2012

    Report

    Report Number
    1045254-2012-00039
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 7, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND A PRODUCT ANALYSIS IS BEING PERFORMED. DEVICE DESCRIPTION - THE STRAIGHTSHOTR 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 STRAIGHTSHOTR AND ALL MAGNUMR MICRODEBRIDER HANDPIECES. INDICATIONS: SINUS INDICATIONS INCLUDE SEPTOPLASTY, REMOVAL OF SEPTAL SPURS, POLYPECTOMY, ANTROSTOMY, ETHMOIDECTOMY/SPHENOETHMOIDECTOMY, FRONTAL SINUS TREPHINATION AND IRRIGATION, FRONTAL SINUS DRILL OUT, ENDOSCOPIC DCR, TRANSSPHENOIDAL PROCEDURES, MAXILLARY SINUS POLYPECTOMY, CIRCUMFERENTIAL MAXILLARY ANTROSTOMY, CHOANAL ATRESIA, SPHENOIDECTOMY, AND MEDIAL, LATERAL, AND POSTERIOR FRONTAL SINUSOTOMY. NASOPHARYNGEAL/LARYNGEAL INDICATIONS INCLUDE ADENOIDECTOMY, TRACHEAL PROCEDURES, LARYNGEAL POLYPECTOMY, LARYNGEAL LESION DEBULKING, TONSILLECTOMY, TONSILLOTOMY FOR OBSTRUCTIVE TONSILLAR DISEASE, REMOVAL OF ENDOBRONCHIAL LESIONS AND SURGICAL MANAGEMENT OF RECURRENT RESPIRATORY PAPILLOMATOSIS (RRP). HEAD AND NECK (ENT) INDICATIONS INCLUDE SOFT TISSUE SHAVING, RHINOPLASTY (NARROWING OF THE BONY VAULT AND REVISION OF THE BONY PYRAMID), REMOVAL AND SHAPING OF BONE DURING RHINOPLASTY PROCEDURES, REMOVAL OF ADIPOSE TISSUE (LIPO DEBRIDEMENT) IN THE MAXILLARY AND MANDIBULAR REGIONS OF THE FACE, REMOVAL OF ACOUSTIC NEUROMA, AND INCISION AND REMOVAL OF SOFT TISSUE DURING PLASTIC, RECONSTRUCTIVE, AND/OR AESTHETIC SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(6); FEMALE. RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT. THE PROCEDURE WAS FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THE BUR WAS USED ON AND OFF FOR PERIODS OF APPROXIMATELY FIVE TO TEN MINUTES PRIOR TO THE BUR BREAKING TOWARD THE END OF THE PROCEDURE. IT WAS NOTED THAT DUE TO THE DIFFICULT ANATOMY, FORCE WAS USED TO GET THE DESIRED OPENING OF THE FRONTAL SINUS. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT AND ANOTHER BUR WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THE DEVICE WAS EVALUATED AND ANALYSIS WAS PERFORMED. THE PRODUCT WAS RETURNED IN THE ORIGINAL POUCH AND LABELING CONFIRMED THE SAMPLE AS THE PRODUCT INVOLVED IN THIS EVENT. THE TIP WAS DETACHED AT THE FIRST SPIRAL WRAP CLOSEST TO THE DISTAL TIP. THE BREAK IS INDICATIVE OF SPIRAL-WRAP FAILURE AS A RESULT OF ELONGATION AND CROSS-SECTION AREA REDUCTION OF THE WRAP. THE RESULTS OF THE PRODUCT ANALYSIS CONFIRMED THE REPORTED MALFUNCTION (BUR BREAK). IT WAS DETERMINED THROUGH ANALYSIS THAT THE BUR BREAK WAS LIKELY THE RESULT OF EXCESSIVE FORCE USED WHILE DRILLING WITH THE BUR IN AN AREA OF DIFFICULT ANATOMY. THE CURRENT INSTRUCTIONS FOR USE FOR THIS PRODUCT WARN ''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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY OF THE FRONTAL SINUS, THE BUR BROKE OFF, RESULTING IN A FIFTEEN MINUTE DELAY IN THE PROCEDURE TO LOCATE THE BUR WITHIN THE SINUS CAVITY. REPORTEDLY, THE BUR WAS IN USE FOR A "LONG PERIOD OF TIME" AND CREATED A "BIT OF TORQUE" AGAINST THE FRONTAL SINUS. THERE WAS NO REPORT OF INJURY TO THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED AND HAS NOT YET BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

    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 XOMED MFG JACKSONVILLE 1883672HS 0205462789

    Patients

    Seq Age Sex Outcome Treatment
    1