BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 4657509 · Received April 3, 2015

    Report

    Report Number
    1045254-2015-00107
    Event Type
    Injury
    Date Received
    April 3, 2015
    Date of Event
    March 12, 2015
    Report Date
    March 12, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). CONCOMITANT DEVICES: 31315059U: BUR 31315059U, ULTRA 5PK 5MM MED LENGTH, LOT 0206655621, MANUFACTURED: 01/31/2013, USE BEFORE: 01/30/2017. INITIAL USE OF DEVICE 31313069U: BUR 31313069U ULTRA 5PK 3MM LONG LENGTH, LOT 0208924699, MANUFACTURED: 11/06/2014, USE BEFORE: 11/05/2018. INITIAL USE OF DEVICE 1845020: ATTACHMENT 1845020 INDIGO OTOL ANGLED, S/N (B)(4), MANUFACTURED: 11/27/2013 PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; DEVICES NOT RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE BURS WERE DISCARDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: 03/12/2015. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER: 04/30/2015. DATE MANUFACTURER RECEIVED: 05/27/2015. PRODUCT EVALUATION: A FAILURE ANALYSIS WAS CONDUCTED ON THE RETURNED INDIGO HANDPIECE AND THE RETURNED ATTACHMENT. THE BURS WERE NOT RETURNED FOR EVALUATION, THEREFORE SIMILAR CONFIGURATION OF BURS WERE UTILIZED DURING FAILURE ANALYSIS TESTING. THE HANDPIECE WITH ATTACHMENT WAS FIRST CHECKED FOR ANY PHYSICAL DAMAGE OR ANOMALIES. NO VISIBLE DAMAGE OR ANOMALIES WERE NOTICED. SAMPLE BURS OF TWO DIFFERENT SIZES WERE TESTED WITH THE HANDPIECE, TO ENSURE THEY LOCKED INTO THE HANDPIECE/ATTACHMENT ASSEMBLY WITHOUT ANY ISSUES. UPON EVALUATION, BOTH SIZES OF BURS LOCKED INTO THE HANDPIECE/ATTACHMENT SECURELY. A SAW BONE WAS USED TO PERFORM SIMULATED USE AT MAXIMUM AND MINIMUM SPEEDS; NO SKIPPING OF THE BURS OCCURRED. AT THIS TIME, THIS FAILURE ANALYSIS REVEALED THAT NO MALFUNCTION/FAULT WAS FOUND ON THE RETURNED ATTACHMENT AND HANDPIECE. THE DEVICES WERE THEN RELEASED TO SERVICE AND REPAIR FOR FURTHER TESTING AND EVALUATION. EVALUATION OF THE 1845000, INDIGO DRILL, IN SERVICE AND REPAIR COULD NOT DUPLICATE CUSTOMERS CONCERN. REPLACED DISCOLORED HOUSING/MOTOR, COLLET AND OTHER PARTS. THE UNIT WAS REPAIRED CLEANED, TESTED, AND PASSED ALL MANUFACTURING SPECIFICATIONS. EVALUATION OF THE 1845020, ANGLED ATTACHMENT, IN SERVICE AND REPAIR FOUND THAT THE BURS WERE NOT LOCKING IN. THE DEVICE WAS FOUND TO HAVE CORRODED BEARINGS; THEY WERE REPLACED AND THE DEVICE WAS TESTED TO SPECIFICATIONS. METHOD: ACTUAL DEVICE EVALUATED; DEVICE-TO-DEVICE INTERACTION TESTING; LABELING EVALUATION; VISUAL INSPECTION. RESULTS: NO FAILURE DETECTED; DEGRADATION PROBLEM. CONCLUSION: NO FAILURE DETECTED, DEVICE OUT OF SPECIFICATION.

    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 "WHILE HE [THE SURGEON] WAS WORKING IN THE PATIENT'S EAR THE DRILL JUMPED AND HE DRILLED A HOLE THROUGH THE PATIENT'S SINUS CAVITY." ADDITIONAL INFORMATION STATES, "HE DIDN'T CHANGE TO A DIFFERENT DRILL. HE JUST CHANGED BURS. AT THE TIME OF THE INCIDENT HE WAS WORKING WITH THE 31315059U AND AFTER THE INCIDENT CHANGED TO THE 31313069U BUT THE DRILL "JUMPED" AGAIN. THIS IS WHEN HE STOPPED THE PROCEDURE." IT WAS CONFIRMED THAT THE CASE WAS COMPLETED SUCCESSFULLY; NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222372 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 206439765

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Other